CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
FDA 510(k) clearance K965059 · decided 1997-03-04
Clearance details
- K-number
- K965059
- Device name
- CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
- Applicant
- Thomas Industries
- Decision
- Substantially Equivalent
- Date received
- 1996-12-18
- Decision date
- 1997-03-04
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sheboygan, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspira recall (Z-2149-2015) | Gardner Denver Thomas Inc | 2015-07-20 |
| THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspira recall (Z-2150-2015) | Gardner Denver Thomas Inc | 2015-07-20 |
| THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspira recall (Z-2151-2015) | Gardner Denver Thomas Inc | 2015-07-20 |