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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 K953719
Device Name HUMAN TUBAL FLUID
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 Received08/09/1995
Decision Date 11/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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