510(k) K061788 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
| Applicant | Boehringer Laboratories, Norristown PA, US |
| Decision | Substantially Equivalent, Jul 11, 2006 |
| Received | Jun 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2010 | Convatec Inc. Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy Terminated |
OMP | None listed |
| Sep 29, 2009 | ConvaTec ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm)
Rx only, Latex Free; Sterile
Health Industry Bar Code: H984BWS4464509A.
Packaged in boxes of 15 uni Terminated |
OMP | None listed |
| Sep 9, 2009 | ConvaTec Engenex Wound Cover; Product Code 446470;
Advanced Negative Pressure Wound Therapy System;
Sterile, Box Contains 10 units.
Boehringer Wound Systems, LLC, Norristown, PA 19404;
Manufactured for: ConvaT Terminated |
OMP | None listed |
| Sep 9, 2009 | ConvaTec Engenex Cover Strip; Product Code 446471;
Advanced Negative Wound Therapy System;
Sterile, Boc contains 10 units;
Boehringer Wound Systems, LLC, Norristown, PA 19404;
Manufactured for: ConvaTec Inc., Terminated |
OMP | None listed |
| Sep 9, 2009 | ConvaTec Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553;
Advanced Negative Pressure Wound Therapy System;
Sterile, box contains 15 units;
Boehringer Wound Systems, LLC, Norristown, PA 1940 Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.