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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 K861455
Device Name MODEL DT-102 DATA TELEPHONE TRANSMITTER
Applicant
Advantage Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
Advantage Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/18/1986
Decision Date 05/30/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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