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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 K903457
Device Name PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
Applicant
PRECISE OPTICS
22 EAST BROADWAY
GARDNER,  MA  01440
Applicant Contact FRANCIS L PUGSLEY
Correspondent
PRECISE OPTICS
22 EAST BROADWAY
GARDNER,  MA  01440
Correspondent Contact FRANCIS L PUGSLEY
Regulation Number876.1500
Classification Product Code
FET  
Date Received08/01/1990
Decision Date 10/19/1990
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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