510(k) K090638 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
| Applicant | Genadyne Biotechnologies, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Apr 29, 2009 |
| Received | Mar 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090638
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.