PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
FDA 510(k) clearance K932853 · decided 1994-02-22
Clearance details
- K-number
- K932853
- Device name
- PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
- Applicant
- Applied Osteo Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-10
- Decision date
- 1994-02-22
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- JEL
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walnut Creek, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.