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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 K053494
Device Name OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
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 Received12/15/2005
Decision Date 03/23/2006
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
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