510(k) K982865 ยท NPK Barrier, Synthetic, Intraoral
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
| Applicant | Atrix Laboratories, Inc., Fort Collins CO, US |
| Decision | Substantially Equivalent, Sep 8, 1998 |
| Received | Aug 13, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2006 | QLT USA, Inc. Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.