510(k) K072384

MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE by Kensey Nash Corp. — Product Code MQV

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