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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 K021890
Device Name G-2 VERSION 3, MODEL 10049
Applicant
VITROLIFE SWEDEN AB
1800 MASSACHUSETTS AVENUE NW
WASHINGTON,  DC  20036 -1800
Applicant Contact GARY L YINGLING
Correspondent
VITROLIFE SWEDEN AB
1800 MASSACHUSETTS AVENUE NW
WASHINGTON,  DC  20036 -1800
Correspondent Contact GARY L YINGLING
Regulation Number884.6180
Classification Product Code
MQL  
Date Received06/10/2002
Decision Date 09/06/2002
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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