Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1421873

FEI Number

3001237209

Entity Name

XEMAX SURGICAL PRODUCTS, INC.

City/State/Country

NAPA, CA, US

Establishment Address

712 CALIFORNIA BLVD., NAPA, CA 94559, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

XEMAX SURGICAL PRODUCTS, INC. (Owner Number: 9033905)

Owner / Operator Contact Address

712 CALIFORNIA BLVD., --, Napa, CA 94559, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-Sponge Cusp-Lok "RIGHT LIGHT Elbow Immobilizer Wrist Immobilizer Accupunch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-08-04
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2014-12-16
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	1992-07-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-02-26
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2013-02-26

Official Correspondent

Daniel Samson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XEMAX SURGICAL PRODUCTS, INC.

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Similar Registrations

Registration Number	Establishment Name	Location
3013391391	HERKIMER COUNTY CHAPTER NYSARC, INC.	Herkimer, NY, US
3012677665	TECHNO PLASTICS INDUSTRIES, INC.	Anasco, PR, US
3038131023	UNITED TECHNOLOGY VIETNAM COMPANY LIMITED	Quang Ha Commune Quang Ninh, VN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3043106338	SHENZHEN SPONGE NEW MATERIAL CO. LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1421873. Last updated year: 2026. Please use registration number 1421873 when referencing this establishment in official correspondence.