EASYGO ASPIRATOR
FDA 510(k) clearance K971749 · decided 1998-04-01
Clearance details
- K-number
- K971749
- Device name
- EASYGO ASPIRATOR
- Applicant
- Precision Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-12
- Decision date
- 1998-04-01
- Days to decision
- 324 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
- Northampton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Easy Go Vac Aspirator, Model PM65. Portable suction unit recall (Z-0307-05) | Precision Medical, Inc. | 2004-12-15 |
| Easy Go Vac Aspirator, Model PM65HG. Portable suction unit recall (Z-0308-05) | Precision Medical, Inc. | 2004-12-15 |