REAMER BIT
FDA 510(k) clearance K930339 · decided 1993-08-06
Clearance details
- K-number
- K930339
- Device name
- REAMER BIT
- Applicant
- Neoligaments, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-25
- Decision date
- 1993-08-06
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- HTW
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leeds, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.