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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 K110612
Device Name FM20
Applicant
MEDIANA CO., LTD.
WONJU MEDICAL IND. PARK
1650-1 DONGHWA-RI, MUNMAK-EUP
WONJU-SI, GANGWON-DO,  KR 220-801
Applicant Contact AMY KIM
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/03/2011
Decision Date 11/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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