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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K963608
Device Name QUANTITATIVE SENTINEL SYSTEM
Applicant
QUANTITATIVE MEDICINE, INC.
61 BARNES PARK RD. NORTH
WALLINGFORD,  CT  06492
Applicant Contact MARIA VITUG FOUTS
Correspondent
QUANTITATIVE MEDICINE, INC.
61 BARNES PARK RD. NORTH
WALLINGFORD,  CT  06492
Correspondent Contact MARIA VITUG FOUTS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received09/10/1996
Decision Date 03/11/1997
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
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