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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 K031015
Device Name EMBRYOGLUE
Applicant
VITROLIFE SWEDEN AB
MOLNDALSVAGEN 30
GOTHENBURG,  SE SE-412 63
Applicant Contact NINA ARVIDSSON
Correspondent
VITROLIFE SWEDEN AB
MOLNDALSVAGEN 30
GOTHENBURG,  SE SE-412 63
Correspondent Contact NINA ARVIDSSON
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/31/2003
Decision Date 06/23/2003
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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