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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 K032366
Device Name BONESOURCE HAC FAST SETTING CEMENT
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49087
Applicant Contact WADE T RUTKOSKIE
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49087
Correspondent Contact WADE T RUTKOSKIE
Regulation Number882.5300
Classification Product Code
GXP  
Date Received08/01/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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