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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 K960726
Device Name EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
Applicant
Evenflo Co., Inc.
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Applicant Contact DONALD E SEGAL
Correspondent
Evenflo Co., Inc.
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Correspondent Contact DONALD E SEGAL
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/22/1996
Decision Date 07/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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