BONESOURCE HAC


Device Classification Name

methyl methacrylate for cranioplasty

510(k) Number K021440
Device Name BONESOURCE HAC
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo, 
MI 
49087

Original Contact wade t rutkoskie
Regulation Number 882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received 05/06/2002
Decision Date 08/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No