FDA 510(k) Application Details - K934011

Device Classification Name Extractor, Vacuum, Fetal

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510(K) Number K934011
Device Name Extractor, Vacuum, Fetal
Applicant NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA, CA US
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Contact MADELEINE F NUCI
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Regulation Number 884.4340

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Classification Product Code HDB
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Date Received 08/17/1993
Decision Date 05/04/1994
Decision SE - Substantially Equivalent
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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