510(k) K082211 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Nov 14, 2008 |
| Received | Aug 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | Smith & Nephew Inc. ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.