FDA 510(k) Application Details - K022594

Device Classification Name Pump, Breast, Powered

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510(K) Number K022594
Device Name Pump, Breast, Powered
Applicant PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE, NJ 07401-1600 US
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Contact PAUL A SIRACUSA
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 08/05/2002
Decision Date 11/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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