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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, uterine contraction, external (for use in clinic)
510(k) Number K903623
Device Name MODEL600 UTERINE ACTIVITY MONITOR
Applicant
COROMETRICS MEDICAL SYSTEMS, INC.
61 BARNES PARK RD. NORTH
P.O. BOX 333
WALLINGFORD,  CT  06492
Applicant Contact BRIAN R BARRY
Correspondent
COROMETRICS MEDICAL SYSTEMS, INC.
61 BARNES PARK RD. NORTH
P.O. BOX 333
WALLINGFORD,  CT  06492
Correspondent Contact BRIAN R BARRY
Regulation Number884.2720
Classification Product Code
HFM  
Date Received08/09/1990
Decision Date 11/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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