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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K974817
Device Name DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
Applicant
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Applicant Contact RICHARD DESLAURIERS
Correspondent
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Correspondent Contact RICHARD DESLAURIERS
Regulation Number872.4880
Classification Product Code
DZL  
Date Received12/23/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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