510(k) K791646
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1979
- Date Received
- August 24, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Cast
- Device Class
- Class I
- Regulation Number
- 880.6185
- Review Panel
- HO
- Submission Type