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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 K891997
Device Name CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
Applicant
Corometrics Medical Systems, Inc.
61 Barnes Park Rd. N.
P.O. Box 333
Wallingford,  CT  06492
Applicant Contact BRIAN R BARRY
Correspondent
Corometrics Medical Systems, Inc.
61 Barnes Park Rd. N.
P.O. Box 333
Wallingford,  CT  06492
Correspondent Contact BRIAN R BARRY
Regulation Number884.2720
Classification Product Code
HFM  
Date Received03/28/1989
Decision Date 06/08/1989
Decision Substantially Equivalent (SESE)
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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