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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 K070135
Device Name VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
Applicant
FERTI PRO N.V.
3722 AVENUE SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
FERTI PRO N.V.
3722 AVENUE SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received01/16/2007
Decision Date 08/16/2007
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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