Data / Medical devices / United States / Winchester Laboratories, LLLP
Winchester Laboratories, LLLP: FDA-registered device maker in Delray Beach, FL, United States, 1 510(k) clearance
Winchester Laboratories, LLLP is registered with the FDA (registration 1424524) in Delray Beach, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1424524
- FEI number
- 3003036307
- Address
- 301 W. Atlantic Avenue SUITE 01, Delray Beach, FL, United States, 33444
- Owner or operator
- WINCHESTER LABORATORIES, LLLP (9041041)
- Roles
- Specification developer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Saljet Single Dose Sterile Saline
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 1999 | K993969 | SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION | FRO | Substantially Equivalent | Winchester Laboratories, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 30, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.