510(k) K960194 ยท HRX Arthroscope
MYELOTEC MYELOSCOPE
| Applicant | Myelotec, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, Sep 4, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2008 | Myelotec, Inc. Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076. Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.