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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 K874631
Device Name HEALTHPHONE TOCO MODEL
Applicant
Carelink
22936 Mill Creek Dr.
Laguna Hills,  CA  92653
Applicant Contact RICHARD C LIGGITT
Correspondent
Carelink
22936 Mill Creek Dr.
Laguna Hills,  CA  92653
Correspondent Contact RICHARD C LIGGITT
Regulation Number884.2720
Classification Product Code
HFM  
Date Received11/10/1987
Decision Date 03/11/1988
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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