FDA 510(k) Application Details - K961993

Device Classification Name Labor And Delivery Kit

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510(K) Number K961993
Device Name Labor And Delivery Kit
Applicant DEVON INDUSTRIES, INC.
9530 DESOTO AVE.
CHATSWORTH, CA 91311-5084 US
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Contact GEORGE AUSTRIA
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Regulation Number 000.0000

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Classification Product Code MLS
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Date Received 05/21/1996
Decision Date 07/03/1996
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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