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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 K960109
Device Name QUANTITATIVE SENTINEL SYSTEM
Original Applicant
QUANTITATIVE MEDICINE, INC.
200 harry s. truman pkwy.
suite 220
annapolis,  MD  21401
Original Contact maria vitug fouts
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/11/1996
Decision Date 08/01/1996
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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