FDA 510(k) Application Details - K964396

Device Classification Name Pump, Breast, Powered

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510(K) Number K964396
Device Name Pump, Breast, Powered
Applicant THE NATURAL CHOICE CO., INC.
1155 CHESS DRIVE, SUITE 115
FOSTER CITY, CA 94404 US
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Contact NANETTE NETTLES
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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 06/06/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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