510(k) K912824
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1991
- Date Received
- June 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Sponge, Surgical
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- SU
- Submission Type