FISK ARM SUPPORT
FDA 510(k) clearance K931876 · decided 1993-09-09
Clearance details
- K-number
- K931876
- Device name
- FISK ARM SUPPORT
- Applicant
- Vvortex International Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-14
- Decision date
- 1993-09-09
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- FWW
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Cordova, CA, US
- Third-party review
- No
- Expedited review
- No
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| UNIVERSAL SURGICAL INSTRUMENT HOLDER (K924713) | T. Korossurgical Instruments Corp. | 1993-05-17 |
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| SKYTRON ELITE 300 SURGERY TABLE (K853479) | Skytron, Div. the Kmw Group, Inc. | 1985-09-05 |
Recalls involving this device
No recalls on record reference this clearance.