MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
FDA 510(k) clearance K993655 · decided 1999-12-21
Clearance details
- K-number
- K993655
- Device name
- MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-29
- Decision date
- 1999-12-21
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall (Z-1866-2016) | Integra LifeSciences Corp. | 2016-05-31 |
| Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall (Z-1867-2016) | Integra LifeSciences Corp. | 2016-05-31 |