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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name methyl methacrylate for cranioplasty
510(k) Number K021440
Device Name BONESOURCE HAC
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49087
Applicant Contact WADE T RUTKOSKIE
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49087
Correspondent Contact WADE T RUTKOSKIE
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received05/06/2002
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
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