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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 K092770
Device Name SIMPLYGO HANDS FREE BREAST PUMP
Applicant
Evenflo Company, Inc.
225 Byers Rd.
Miamisburg,  OH  45342
Applicant Contact AMY NEFF
Correspondent
Evenflo Company, Inc.
225 Byers Rd.
Miamisburg,  OH  45342
Correspondent Contact AMY NEFF
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/09/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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