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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 K022295
Device Name G-RINSE, MODEL 10031
Applicant
VITROLIFE SWEDEN AB
MOLNDALSVAGEN 30
GOTHENBURG,  SE SE-412 63
Applicant Contact EILER ANDERSON
Correspondent
VITROLIFE SWEDEN AB
MOLNDALSVAGEN 30
GOTHENBURG,  SE SE-412 63
Correspondent Contact EILER ANDERSON
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/16/2002
Decision Date 09/12/2002
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
Predetermined Change
Control Plan Authorized		 No
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