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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 K032154
Device Name G-FREEZEKIT BLAST
Applicant
Vitrolife AB
1800 Massachusetts Ave. NW
Washington,  DC  20036 -1800
Applicant Contact GARY L YINGLING
Correspondent
Vitrolife AB
1800 Massachusetts Ave. NW
Washington,  DC  20036 -1800
Correspondent Contact GARY L YINGLING
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/14/2003
Decision Date 05/07/2004
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 Yes
Predetermined Change
Control Plan Authorized		 No
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