510(k) K062413
K062413 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP PNEUMATIC KERRISON". The FDA issued a decision of Substantially Equivalent on November 21, 2006. The device falls under product code HAD (Rongeur, Powered), a Class II device regulated under 21 CFR 882.4845. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2006
- Date Received
- August 17, 2006
- 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