510(k) K832068
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1983
- Date Received
- June 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tack, Sacculotomy (Cody Tack)
- Device Class
- Class II
- Regulation Number
- 874.3760
- Review Panel
- EN
- Submission Type