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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 K991398
Device Name BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact KRISTYN R KELLEY
Correspondent
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact KRISTYN R KELLEY
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received04/22/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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