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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 K012220
Device Name TAO EMBRYO TRANSFER CATHETER SYSTEM
Applicant
TTJ BIOMEDICAL, LLC.
2885 AURORA AVENUE, SUITE 15
BOULDER,  CO  80303
Applicant Contact RICHARD JORTBERG
Correspondent
TTJ BIOMEDICAL, LLC.
2885 AURORA AVENUE, SUITE 15
BOULDER,  CO  80303
Correspondent Contact RICHARD JORTBERG
Regulation Number884.6110
Classification Product Code
MQF  
Date Received07/16/2001
Decision Date 08/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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