PC-MINI
FDA 510(k) clearance K934367 · decided 1993-11-08
Clearance details
- K-number
- K934367
- Device name
- PC-MINI
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1993-09-07
- Decision date
- 1993-11-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JYD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.