510(k) K992216 ยท LYC Bone Grafting Material, Synthetic
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Jul 26, 1999 |
| Received | Jul 1, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2013 | Integra LifeSciences Corporation BioMend Extend" Absorbable Collagen Membrane
BioMend Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodo Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.