SYNTHES HEMOSTATIC BONE PUTTY (HBP)


Device Classification Name

wax,bone

510(k) Number K103822
Device Name SYNTHES HEMOSTATIC BONE PUTTY (HBP)
Applicant
SYNTHES USA PRODUCTS, LLC
1230 wilson blvd.
west chester, 
PA 
19380

Applicant Contact jeffrey l dow
Correspondent
SYNTHES USA PRODUCTS, LLC
1230 wilson blvd.
west chester, 
PA 
19380

Correspodent Contact jeffrey l dow
Classification Product Code
MTJ  
Date Received 12/30/2010
Decision Date 05/19/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls