Data / Medical devices / United States / Prime Distributors LLC
Prime Distributors LLC: FDA-registered device maker in Brooklyn, NY, United States, 1 510(k) clearance
Prime Distributors LLC is registered with the FDA (registration 3004585750) in Brooklyn, NY, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004585750
- Address
- 1769 48th St, Brooklyn, NY, United States, 11204
- Owner or operator
- PRIME DISTRIBUTORS LLC (9063520)
- Roles
- Repackager or relabeler
- First device listed
- May 14, 2004
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Pad, Menstrual, Unscented
- All makers of Garment, Protective, For Incontinence
- All makers of Floss, Dental
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Lens, Contact, (Disposable)
Updated October 28, 2004. 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.