ROTAX-II BI-PLANE CIRCULAR ARM
FDA 510(k) clearance K870205 · decided 1987-03-06
Clearance details
- K-number
- K870205
- Device name
- ROTAX-II BI-PLANE CIRCULAR ARM
- Applicant
- B C Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-20
- Decision date
- 1987-03-06
- Days to decision
- 45 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Canada, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.