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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 K000989
Device Name SPERM WASH MEDIUM, CAT# 2003/2005
Applicant
INVITROCARE, INC.
11408 SORRENTO VALLEY RD.
SUITE 202
SAN DIEGO,  CA  92121
Applicant Contact RPBERT E LOVINS
Correspondent
INVITROCARE, INC.
11408 SORRENTO VALLEY RD.
SUITE 202
SAN DIEGO,  CA  92121
Correspondent Contact RPBERT E LOVINS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received03/28/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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