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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 K082307
Device Name EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
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 Received08/13/2008
Decision Date 09/11/2008
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
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