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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 K023403
Device Name SPERMGRAD, MODELS 10022/10063
Applicant
Vitrolife Sweden AB
Molndalsvagen 30
Gothenberg,  SE SE-41263
Applicant Contact NINA ARVIDSSON
Correspondent
Vitrolife Sweden AB
Molndalsvagen 30
Gothenberg,  SE SE-41263
Correspondent Contact NINA ARVIDSSON
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/10/2002
Decision Date 12/13/2002
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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