Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1424524

FEI Number

3003036307

Entity Name

WINCHESTER LABORATORIES, LLLP

City/State/Country

Delray Beach, FL, US

Establishment Address

301 W. Atlantic Avenue, SUITE 01, Delray Beach, FL 33444, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

WINCHESTER LABORATORIES, LLLP (Owner Number: 9041041)

Owner / Operator Contact Address

301 W. Atlantic Ave., SUITE 1, Delray Beach, FL 33444, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993969

PMA Number

N/A

All Registered Proprietary Names

Saljet Single Dose Sterile Saline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WINCHESTER LABORATORIES, LLLP

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1424524. Last updated year: 2026. Please use registration number 1424524 when referencing this establishment in official correspondence.