510(k) K922961
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- March 23, 1993
- Date Received
- June 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type