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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 K121478
Device Name NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
Applicant
MAPA GMBH
728 BOOSTER BLVD.
REEDSBURG,  WI  53959
Applicant Contact MARK WOZNIAK
Correspondent
MAPA GMBH
728 BOOSTER BLVD.
REEDSBURG,  WI  53959
Correspondent Contact MARK WOZNIAK
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/18/2012
Decision Date 04/05/2013
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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