510(k) K970185 ยท KKX Drape, Surgical, Antimicrobial
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
| Applicant | Contour Fabricators, Inc., Grand Blanc MI, US |
| Decision | Substantially Equivalent, Apr 10, 1997 |
| Received | Jan 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2009 | GE Medical Systems, LLC GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Lower, Part Number 888944-01. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Sterile, Drape, Headset, Upper, Part Number 888945-01. Terminated |
MMP | None listed |
| Sep 1, 2009 | GE Medical Systems, LLC Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper). Terminated |
MMP | None listed |
| Aug 14, 2009 | GE Medical Systems, LLC GE Healthcare, Drapes and Sterile Covers
PART NUMBER DESCRIPTION
00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL
00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AN Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.