FORCEPS, COAGULATION, BIPOLAR, MALIS
FDA 510(k) clearance K911377 · decided 1991-04-19
Clearance details
- K-number
- K911377
- Device name
- FORCEPS, COAGULATION, BIPOLAR, MALIS
- Applicant
- International Hospital Supply Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-28
- Decision date
- 1991-04-19
- Days to decision
- 22 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
- Tarzana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.