FDA 510(k) Application Details - K962828

Device Classification Name Pump, Breast, Non-Powered

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510(K) Number K962828
Device Name Pump, Breast, Non-Powered
Applicant GENESIS INDUSTRIES, INC.
601 PRO-JECT DR.
ELMWOOD, WI 54740 US
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Contact SYLVAN JOHNSON
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Regulation Number 884.5150

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Classification Product Code HGY
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Date Received 07/19/1996
Decision Date 02/10/1997
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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