Data / Medical devices / United States / Premier Brands of America Inc.
Premier Brands of America Inc.: FDA-registered device maker in Hudson, NY, United States, 1 510(k) clearance
Premier Brands of America Inc. is registered with the FDA (registration 3014258951) in Hudson, NY, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014258951
- Address
- 351 Fairview Ave, Hudson, NY, United States, 12534
- Owner or operator
- PREMIER BRANDS OF AMERICA INC. (2434554)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 22, 1988
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 17, 2009 | K090848 | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | FQH | Substantially Equivalent | Premier Brands of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lavage, Jet
- All makers of Dressing, Wound, Drug
- All makers of Orthosis, Corrective Shoe
- All makers of Protector, Skin Pressure
Updated June 17, 2009. 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.