FDA 510(k) Application Details - K023017

Device Classification Name Catheter, Assisted Reproduction

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510(K) Number K023017
Device Name Catheter, Assisted Reproduction
Applicant FERTILITY TECHNOLOGY RESOURCES, INC.
4343 SHALLOWFORD RD.
SUITE D-4
MARIETTA, GA 30062 US
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Contact THOMAS J ZINNANTI
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Regulation Number 884.6110

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Classification Product Code MQF
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Date Received 09/10/2002
Decision Date 12/13/2002
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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