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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K941919
Device Name OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
Applicant
OKTAS
171 MAIN ST.
SUITE 101
ASHLAND,  MA  01721 -1818
Applicant Contact KEN HORI
Correspondent
OKTAS
171 MAIN ST.
SUITE 101
ASHLAND,  MA  01721 -1818
Correspondent Contact KEN HORI
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/20/1994
Decision Date 06/17/1994
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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