510(k) K072384
K072384 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE". The FDA issued a decision of Substantially Equivalent on September 21, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2007
- Date Received
- August 24, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type