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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, battery-powered and accessories
510(k) Number K925276
Device Name M.I.S. TROCAR-CANNULA
Applicant
M.I.S. TECHNOLOGY, INC.
7015 147TH SW
EDMONDS,  WA  98026
Applicant Contact MICHAEL LAU
Correspondent
M.I.S. TECHNOLOGY, INC.
7015 147TH SW
EDMONDS,  WA  98026
Correspondent Contact MICHAEL LAU
Regulation Number876.1500
Classification Product Code
GCS  
Date Received10/20/1992
Decision Date 05/24/1993
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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