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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K133568
Device Name G-TL
Applicant
Vitrolife, Inc.
3601 S. Inca St.
Englewood,  CO  80110
Applicant Contact MARK LARMAN
Correspondent
Vitrolife, Inc.
3601 S. Inca St.
Englewood,  CO  80110
Correspondent Contact MARK LARMAN
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/20/2013
Decision Date 07/16/2014
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
Predetermined Change
Control Plan Authorized		 No
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