510(k) K071442 ยท FRO Dressing, Wound, Drug
SUPRASORB A +AG
| Applicant | Specialty Fibres and Materials, Ltd., Coventry, GB |
| Decision | Substantially Equivalent, May 1, 2008 |
| Received | May 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2015 | TZ Medical Inc. Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.