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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K100929
Device Name UNIMOM ALLEGRO
Applicant
Blue Egg CO
216-5 Yongmoon-Dong, Seo-Ku
Daejon, Korea,  KR
Applicant Contact HONG J HYUN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC MOUSER
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/05/2010
Decision Date 06/16/2010
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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