510(k) K061919 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
| Applicant | Blue Sky Medical Group Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 5, 2007 |
| Received | Jul 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2016 | Smith & Nephew, Inc. RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film
Is intended for patients who would benefit from a suction device (negative pressur Open, Classified |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.