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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 K002836
Device Name MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
Applicant
SAGE BIOPHARMA
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
SAGE BIOPHARMA
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received09/12/2000
Decision Date 10/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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