HM-88011 SOLID STATE ELECTR SURGICAL UNIT
FDA 510(k) clearance K961473 · decided 1996-05-07
Clearance details
- K-number
- K961473
- Device name
- HM-88011 SOLID STATE ELECTR SURGICAL UNIT
- Applicant
- Hill-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-17
- Decision date
- 1996-05-07
- Days to decision
- 20 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
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.