Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007867838

FEI Number

1000161215

Entity Name

Sanmina

City/State/Country

SAN JOSE, CA, US

Establishment Address

2700 N 1st St, SAN JOSE, CA 95134, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sanmina Corporation (Owner Number: 2129538)

Owner / Operator Contact Address

13000 S. Memorial Pkwy, --, Huntsville, AL 35803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMPACT INTUITIV System be.well COVID-19 Test Kits C+B (laser skin surface care) OVB1 HD Camera System Sovereign Cmpact DC Powered IV Pole TELIGEN C+B (laser skin surface care)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2014-06-11
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2022-03-07
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2016-10-24
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2016-11-08
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2014-03-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-12-07
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2016-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sanmina Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004139819	Sanmina Ireland UC	FERMOY, CORK Munster, IE
3004201275	SANMINA-SCI AB	SJALEVAD Vasternorrland, SE
3009609218	Sanmina Corporation	Carrollton, TX, US
3004016520	SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.	Maalot-Tarshiha Northern, IL
3007923088	Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Z-2109-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
2028159	Alcon Research, LLC	IRVINE, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	SCHIPOL RIJK Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007867838. Last updated year: 2026. Please use registration number 3007867838 when referencing this establishment in official correspondence.