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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, non-powered
510(k) Number K013226
Device Name EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
Applicant
EVENFLO COMPANY, INC.
1000 EVENFLO DR.
P.O. BOX 709
CANTON,  GA  30114
Applicant Contact MATTHEW G MCCARTY
Correspondent
EVENFLO COMPANY, INC.
1000 EVENFLO DR.
P.O. BOX 709
CANTON,  GA  30114
Correspondent Contact MATTHEW G MCCARTY
Regulation Number884.5150
Classification Product Code
HGY  
Date Received09/27/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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