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FDA 510(k) Application Details - K041470
Device Classification Name
Catheter, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K041470
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
CONSTANCE W STURGEON
Other 510(k) Applications for this Contact
Regulation Number
884.6110
More FDA Info for this Regulation Number
Classification Product Code
MQF
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More FDA Info for this Product Code
Date Received
06/02/2004
Decision Date
11/22/2004
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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