510(k) K022907
K022907 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH POWERED KERRISON SYSTEM (PKS)". The FDA issued a decision of Substantially Equivalent on October 21, 2002. The device falls under product code HAD (Rongeur, Powered), a Class II device regulated under 21 CFR 882.4845. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2002
- Date Received
- September 3, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Powered
- Device Class
- Class II
- Regulation Number
- 882.4845
- Review Panel
- NE
- Submission Type