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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 K023717
Device Name SPERM WASH MEDIUM WITH GENTAMICIN
Applicant
CONCEPTION TECHNOLOGIES
6835 FLANDERS DR. SUITE 500
SAN DIEGO,  CA  92121
Applicant Contact JOHN CORCORAN
Correspondent
CONCEPTION TECHNOLOGIES
6835 FLANDERS DR. SUITE 500
SAN DIEGO,  CA  92121
Correspondent Contact JOHN CORCORAN
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/05/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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