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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 K101003
Device Name RAPIDVIT BLAST, RAPIDWARM BLAST
Applicant
Vitrolife Sweden AB
Box 9080
Se-400 92 Goteborg,  SE
Applicant Contact KJELL KJORK
Correspondent
Vitrolife Sweden AB
Box 9080
Se-400 92 Goteborg,  SE
Correspondent Contact KJELL KJORK
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/12/2010
Decision Date 12/10/2010
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 Yes
Predetermined Change
Control Plan Authorized		 No
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