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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 K022933
Device Name EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
Applicant
EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA,  OH  45377
Applicant Contact MATTHEW G MCCARTY
Correspondent
EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA,  OH  45377
Correspondent Contact MATTHEW G MCCARTY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/04/2002
Decision Date 12/02/2002
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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