CARE-E-VAC 3
FDA 510(k) clearance K062610 · decided 2006-09-28
Clearance details
- K-number
- K062610
- Device name
- CARE-E-VAC 3
- Applicant
- Ohio Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-09-05
- Decision date
- 2006-09-28
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gurnee, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 7 recall (Z-2995-2018) | Ohio Medical Corporation | 2018-09-07 |
| Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 11 recall (Z-0833-2011) | Ohio Medical Corporation | 2010-12-29 |