SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES
FDA 510(k) clearance K934332 · decided 1994-03-25
Clearance details
- K-number
- K934332
- Device name
- SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES
- Applicant
- Friatec Medical Inc., USA
- Decision
- Substantially Equivalent
- Date received
- 1993-09-07
- Decision date
- 1994-03-25
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.