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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 K991346
Device Name PH-100, MODEL 2104
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 Received04/19/1999
Decision Date 02/24/2000
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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