FDA 510(k) Application Details - K040717

Device Classification Name Labware, Assisted Reproduction

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510(K) Number K040717
Device Name Labware, Assisted Reproduction
Applicant NUNC A/S
KAMSTRUPUEJ 90, KAMSTRUP
ROSKILDE DK-4000 DK
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Contact HENRIK KVISTGAARD
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Regulation Number 884.6160

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Classification Product Code MQK
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Date Received 03/19/2004
Decision Date 08/12/2004
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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