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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 K920026
Device Name NOBLES-LAI IMAGING SYSTEM
Applicant
Nobles-Lai Engineering, Inc.
3178 Pullman St.
Costa Mesa,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
Nobles-Lai Engineering, Inc.
3178 Pullman St.
Costa Mesa,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received01/03/1992
Decision Date 07/28/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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