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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 K113315
Device Name RUMBLE TUFF
Applicant
ACUTE IDEAS CO. LTD.
865 N 1430 W
OREM,  UT  84057
Applicant Contact MATTHEW KHO
Correspondent
ACUTE IDEAS CO. LTD.
865 N 1430 W
OREM,  UT  84057
Correspondent Contact MATTHEW KHO
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/09/2011
Decision Date 11/20/2012
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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