510(k) K060878 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
| Applicant | Curamedical, BV, Claremont NH, US |
| Decision | Substantially Equivalent, Apr 13, 2006 |
| Received | Mar 31, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2022 | GELITA MEDICAL GMBH ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM Terminated |
LYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.