510(k) K092878 ยท FRO Dressing, Wound, Drug
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
| Applicant | Prugen IP Holdings, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jan 15, 2010 |
| Received | Sep 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092878
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.