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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 K011736
Device Name DRG QUICKMIX
Applicant
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Applicant Contact RICHARD DESLAURIES
Correspondent
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Correspondent Contact RICHARD DESLAURIES
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received06/05/2001
Decision Date 01/30/2002
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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