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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, intrauterine insemination
510(k) Number K923612
Device Name MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
houston,  TX  77236 -6221
Applicant Contact gary j sfeir
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
houston,  TX  77236 -6221
Correspondent Contact gary j sfeir
Regulation Number884.5250
Classification Product Code
MFD  
Date Received07/21/1992
Decision Date 09/07/1993
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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