510(k) K091470 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Jul 9, 2009 |
| Received | May 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2010 | Smith & Nephew Inc. smith&nephew EZCARE Negative Pressure Rx only.
100-240 V 12 V 50/60 Hz 90VA T1A 250 V
Indicated for patients who would benefit from a suction device particularly as the device may promote healing Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.