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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K012535
Device Name DRG DISPOSABLE VAGINAL SPECULUM
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 Number884.4530
Classification Product Code
HIB  
Date Received08/07/2001
Decision Date 03/01/2002
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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