FDA 510(k) Application Details - K051112

Device Classification Name Pump, Breast, Powered

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510(K) Number K051112
Device Name Pump, Breast, Powered
Applicant WHITTLESTONE, INC.
602 B STONE RD.
BENICIA, CA 94510 US
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Contact BRUCE MCKENDRY
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 05/02/2005
Decision Date 09/07/2005
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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