510(k) K091692
K091692 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP PEEK CRANIOFIX". The FDA issued a decision of Substantially Equivalent on August 12, 2010. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2010
- Date Received
- June 10, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Burr Hole
- Device Class
- Class II
- Regulation Number
- 882.5250
- Review Panel
- NE
- Submission Type