510(k) K872797
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1987
- Date Received
- July 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Shoe, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type