Data / Medical devices / United States / Primus Pharmaceuticals, Inc.
Primus Pharmaceuticals, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 2 510(k) clearances
Primus Pharmaceuticals, Inc. is registered with the FDA (registration 3006052875) in Scottsdale, AZ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 11, 2006. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006052875
- Address
- 7373 N Scottsdale RD Ste B200, Scottsdale, AZ, United States, 85253
- Owner or operator
- Primus Pharmaceuticals (10057500)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 16, 2018
- Registered through
- 2027
- Brand names listed
- EpiCeram, Promiseb Topical Cream, Telescopic Medical Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Specification developer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| October 11, 2006 | K050158 | SINCLAIR SEBORRHEA EMULSION | FRO | Substantially Equivalent | Sinclair Pharmaceuticals, Ltd. | accessdata.fda.gov |
| April 11, 2006 | K052643 | EPICERAM | FRO | Substantially Equivalent | Ceragenix Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated October 11, 2006. 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.