STERILE DISPOSABLE EQUIPMENT MAGNET COVER
FDA 510(k) clearance K970185 · decided 1997-04-10
Clearance details
- K-number
- K970185
- Device name
- STERILE DISPOSABLE EQUIPMENT MAGNET COVER
- Applicant
- Contour Fabricators, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-17
- Decision date
- 1997-04-10
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Grand Blanc, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Dist recall (Z-1706-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Sterile, Drape, Headset, Lower, Part Number 888944-01. recall (Z-1707-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Sterile, Drape, Headset, Upper, Part Number 888945-01. recall (Z-1708-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile recall (Z-1709-2009) | GE Medical Systems, LLC | 2009-09-01 |
| GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/ recall (Z-1730-2009) | GE Medical Systems, LLC | 2009-08-14 |