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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 K022594
Device Name PLAYTEX BREAST PUMP
Applicant
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact PAUL A SIRACUSA
Correspondent
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact PAUL A SIRACUSA
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/05/2002
Decision Date 11/01/2002
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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