510(k) K903946
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1990
- Date Received
- August 27, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, Cast
- Device Class
- Class I
- Regulation Number
- 888.5940
- Review Panel
- OR
- Submission Type