MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072384
Device Name MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
Applicant
KENSEY NASH CORP.
735 pennsylvania drive
exton, 
PA 
19341

Applicant Contact jennifer j bosley
Correspondent
KENSEY NASH CORP.
735 pennsylvania drive
exton, 
PA 
19341

Correspodent Contact jennifer j bosley
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/24/2007
Decision Date 09/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No