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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, cranioplasty, preformed, alterable
510(K) Number K121153
Device Name PEEK CUSTOMIZED CRAIAL IMPLANT KIT
Applicant
STRYKER
750 trade centre way
ste 200
portage,  MI  49002
Contact manish patel
Regulation Number882.5320
Classification Product Code
GWO  
Date Received04/16/2012
Decision Date 09/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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