510(k) K981636 ยท HRX Arthroscope
INTEGRATED DRIVE/PUMP SYSTEM
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Aug 20, 1998 |
| Received | May 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2004 | Linvatec Corp. Ultra Power Burs, Sterile, Single-Use. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.