FDA 510(k) Application Details - K070435

Device Classification Name Pump, Breast, Powered

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510(K) Number K070435
Device Name Pump, Breast, Powered
Applicant WHITTLESTONE, INC.
102 HERITAGE AVE
CASTLE ROCK, CO 80104-y US
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Contact GLEN THIBAULT
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 02/15/2007
Decision Date 07/17/2007
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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