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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 K120352
Device Name STRYKER QUIKFLAP STERILE PROCEDURE PACK
Applicant
Stryker
750 Trade Center Way
Suite 200
Porage,  MI  49002
Applicant Contact JAMSHED BADARPURA
Correspondent
Stryker
750 Trade Center Way
Suite 200
Porage,  MI  49002
Correspondent Contact JAMSHED BADARPURA
Regulation Number882.5320
Classification Product Code
GWO  
Date Received02/06/2012
Decision Date 06/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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