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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, biliary, surgical
510(k) Number K913294
Device Name SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
Applicant
SURGITEK MEDICAL ENGINEERING CORP.
3037 mt. pleasant st.
racine,  WI  53404
Applicant Contact william h duffell
Correspondent
SURGITEK MEDICAL ENGINEERING CORP.
3037 mt. pleasant st.
racine,  WI  53404
Correspondent Contact william h duffell
Regulation Number876.5010
Classification Product Code
GCA  
Date Received07/24/1991
Decision Date 10/04/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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