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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 K052909
Device Name EVENFLO ELAN BREAST PUMP
Applicant
Evenflo Company, Inc.
707 Crossroads Ct.
Vandalia,  OH  45377
Applicant Contact THOMAS A SPARNO
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MORTEN SIMON CHRISTENESEN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/17/2005
Decision Date 11/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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