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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 K050826
Device Name FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
Applicant
CETRO AMERICA
925 SHERMAN AVENUE
HAMDEN,  CT  06514
Applicant Contact MAYA CIANCIOLO
Correspondent
CETRO AMERICA
925 SHERMAN AVENUE
HAMDEN,  CT  06514
Correspondent Contact MAYA CIANCIOLO
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/01/2005
Decision Date 04/10/2006
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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