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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, assisted reproduction
510(k) Number K032208
Device Name MONA LISA ASPIRATION NEEDLE
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 Number884.6100
Classification Product Code
MQE  
Date Received07/18/2003
Decision Date 12/09/2003
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
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