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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, rectal
510(k) Number K964634
Device Name ANOKRYO
Applicant
MK CONQUEST INTL., INC.
100 EAST 15TH ST.
SUITE 320
FORT WORTH,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
MK CONQUEST INTL., INC.
100 EAST 15TH ST.
SUITE 320
FORT WORTH,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number876.5450
Classification Product Code
FFP  
Subsequent Product Code
LKX  
Date Received11/19/1996
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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