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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 K951835
Device Name MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE
Applicant
Life Technologies, Inc.
3175 Staley Rd.
P. O. Box 68
Grand Island,  NY  14072
Applicant Contact KEITH D GITTERMANN
Correspondent
Life Technologies, Inc.
3175 Staley Rd.
P. O. Box 68
Grand Island,  NY  14072
Correspondent Contact KEITH D GITTERMANN
Regulation Number884.5250
Classification Product Code
MFD  
Date Received04/20/1995
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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