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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K041470
Device Name MORTON IUI CATHETERS
Applicant
FERTILITY TECHNOLOGY RESOURCES, INC.
4343 SHALLOWFORD RD.
SUITE D-4
MARIETTA,  GA  30062
Applicant Contact CONSTANCE W STURGEON
Correspondent
FERTILITY TECHNOLOGY RESOURCES, INC.
4343 SHALLOWFORD RD.
SUITE D-4
MARIETTA,  GA  30062
Correspondent Contact CONSTANCE W STURGEON
Regulation Number884.6110
Classification Product Code
MQF  
Date Received06/02/2004
Decision Date 11/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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