CRUCIOMETER
FDA 510(k) clearance K884483 · decided 1989-01-18
Clearance details
- K-number
- K884483
- Device name
- CRUCIOMETER
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-25
- Decision date
- 1989-01-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- JZE
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.