510(k) K152055 ยท FRO Dressing, Wound, Drug
Ceramax Skin Barrier Cream
| Applicant | Oculus Innovative Sciences, Petaluma CA, US |
| Decision | Substantially Equivalent, Nov 23, 2015 |
| Received | Jul 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2016 | Oculus Innovative Sciences, Inc. Ceramax Skin Barrier Cream:
NET WT 0.1 OZ (3 g professional sample - not for retail sale)
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care pr Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.