SAFETY HOLSTER, SINGLE-USE
FDA 510(k) clearance K790770 · decided 1979-05-18
Clearance details
- K-number
- K790770
- Device name
- SAFETY HOLSTER, SINGLE-USE
- Applicant
- Aspen Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-20
- Decision date
- 1979-05-18
- Days to decision
- 28 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
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 13766 recall (Z-0726-2013) | ConMed Corporation | 2013-01-24 |