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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 K874071
Device Name MOTHER'S MILK BAG
Applicant
Yanase Waitch K.K.
Higashi, P.O. Box 104
Osaka, 540-91
Japan,  JP
Applicant Contact YANASE
Correspondent
Yanase Waitch K.K.
Higashi, P.O. Box 104
Osaka, 540-91
Japan,  JP
Correspondent Contact YANASE
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/06/1987
Decision Date 12/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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