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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 K061013
Device Name PLAYTEX EMBRACE PETITE BREAST PUMP
Applicant
Playtex Products, Inc.
75 Commerce Dr.
Allendale,  NJ  07401 -1600
Applicant Contact KARIN E JORDAN
Correspondent
Playtex Products, Inc.
75 Commerce Dr.
Allendale,  NJ  07401 -1600
Correspondent Contact KARIN E JORDAN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/13/2006
Decision Date 08/15/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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