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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart-Valve Movement, Fetal, Ultrasonic
510(k) Number K012003
Device Name DRG REACTION CHAMBER/SAFETY TIP
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 Number884.2660
Classification Product Code
HEI  
Date Received06/27/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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