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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 K013518
Device Name EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Applicant Contact WENDELL LEE
Correspondent
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Correspondent Contact WENDELL LEE
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/23/2001
Decision Date 01/18/2002
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
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