510(k) K071237

COPIOS BONE VOID FILLER SPONGE AND PASTE by Kensey Nash Corp. — Product Code MQV

K071237 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "COPIOS BONE VOID FILLER SPONGE AND PASTE". The FDA issued a decision of Substantially Equivalent on June 1, 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
June 1, 2007
Date Received
May 3, 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