510(k) K042134 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
VERSATILE 1 WOUND VACUUM SYSTEM
| Applicant | Blue Sky Medical Group Incorporated, Vista CA, US |
| Decision | Substantially Equivalent, Nov 1, 2004 |
| Received | Aug 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2008 | Smith And Nephew, Inc. Wound Management Division GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.
Indicated for patients who would benefit from a suction device particularly as the device m Terminated |
BTA | None listed |
| Aug 6, 2008 | Smith And Nephew, Inc. Wound Management Division FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product.
Indicated for patients who wold benefit from a suction device particul Terminated |
BTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.