FDA 510(k) Application Details - K992307

Device Classification Name Catheter, Assisted Reproduction

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510(K) Number K992307
Device Name Catheter, Assisted Reproduction
Applicant FERTILITY TECHNOLOGY RESOURCES, INC.
4343 SHALLOWFORD RD.
SUITE D-4
MARIETTA, GA 30062 US
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Regulation Number 884.6110

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Classification Product Code MQF
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Date Received 07/09/1999
Decision Date 09/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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