510(k) K162129 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS-G Gauze Dressing Kits with Soft Port
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | Aug 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162129
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.