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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K110630
Device Name F10
Applicant
Mediana Co., Ltd.
1650-1 Donghwa-Ri
Munmak-Cup
Wonju-City, Gangwon-Do,  KR 220-801
Applicant Contact AMY M.H. KIM
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number884.2660
Classification Product Code
KNG  
Date Received03/03/2011
Decision Date 06/24/2011
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
Predetermined Change
Control Plan Authorized		 No
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