510(k) K100916
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2010
- Date Received
- April 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type