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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 K093648
Device Name SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
Applicant
SIMPLISSE INC.
1340 WEST PENNSYLVANIA AVE
SAN DIEGO,  CA  92103
Applicant Contact Glen Feye
Correspondent
SIMPLISSE INC.
1340 WEST PENNSYLVANIA AVE
SAN DIEGO,  CA  92103
Correspondent Contact Glen Feye
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/25/2009
Decision Date 07/14/2010
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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