FDA 510(k) Application Details - K964403

Device Classification Name Pump, Breast, Powered

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510(K) Number K964403
Device Name Pump, Breast, Powered
Applicant THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON, MA 02322 US
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Contact ANTHONY PAOLO
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 11/04/1996
Decision Date 01/13/1997
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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