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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 K043334
Device Name BONE SOURCE HAC RAPID SETTING CEMENT
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact WADE T RUTKOSKIE
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact WADE T RUTKOSKIE
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received12/03/2004
Decision Date 02/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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