Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009381954

FEI Number

3009381954

Entity Name

COLE INSTRUMENTS

City/State/Country

Alpharetta, GA, US

Establishment Address

1090 Powers Pl, Alpharetta, GA 30009, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

Cole Instruments (Owner Number: 10038436)

Owner / Operator Contact Address

1070 Powers Place, Alpharetta, GA 30009, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aide To Extract ATOE Assist to Extract Assist to Hairline Device - Reusable Cole Electric Chilling Device Graft Washing Station Electric Chilling Device Single Electric Chilling Device Double Powered Cole Isolation Device PCID SFD valve accessory Ring Cup 2-pocket Tweezers Graft Cleaning Bowl Donor Template AHSAD Graft Storage Plate Vortex Cole Instruments Punch CII Punch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2011-10-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-12-05
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-10-21
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2013-12-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-12-12
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2022-12-05
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2021-12-13
IDX	Sieves, Tissue	Pathology	Class 1	864.3010	2021-12-13
HWT	Template	Orthopedic	Class 1	888.4800	2021-12-13
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2022-12-05
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2012-12-17
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-10-13

Official Correspondent

Chris Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cole Instruments

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3029082594	CHOOSE SURGICAL INSTRUMENTS	Sialkot Punjab, PK
3006410968	ROBINSON HEALTHCARE LIMITED	Worksop Nottinghamshire, GB
3004598675	WASHINGTON SURGICAL INTERNATIONAL	SIALKOT Punjab, PK
9614084	MEDICAL DEVICES (PVT) LTD.	Sialkot Punjab, PK
3003644849	DR. FRIGZ INTERNATIONAL (PVT) LTD.	SIALKOT, Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009381954. Last updated year: 2026. Please use registration number 3009381954 when referencing this establishment in official correspondence.