VERSATILE 1 WOUND VACUUM SYSTEM
FDA 510(k) clearance K042134 · decided 2004-11-01
Clearance details
- K-number
- K042134
- Device name
- VERSATILE 1 WOUND VACUUM SYSTEM
- Applicant
- Blue Sky Medical Group Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-11-01
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-501 recall (Z-0162-2009) | Smith And Nephew, Inc. Wound Management Division | 2008-10-27 |
| FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 recall (Z-1620-2008) | Smith And Nephew, Inc. Wound Management Division | 2008-08-06 |