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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uterine electromyographic monitor
510(k) Number K101801
FOIA Releasable 510(k) K101801
Device Name MONICA AN24
Applicant
MONICA HEALTHCARE
PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Applicant Contact IAN HOW
Correspondent
MONICA HEALTHCARE
PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Correspondent Contact IAN HOW
Regulation Number884.2720
Classification Product Code
OSP  
Subsequent Product Code
HGM  
Date Received06/28/2010
Decision Date 02/03/2011
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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