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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 K822959
Device Name ENDOSCOPIC VIDEOSYSTEM
Applicant
EDER INSTRUMENT CO, INC.
735 NORTH WATER ST.
SUITE 1102
MILWAUKEE, WI 53202,  53202
Correspondent
EDER INSTRUMENT CO, INC.
735 NORTH WATER ST.
SUITE 1102
MILWAUKEE, WI 53202,  53202
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/05/1982
Decision Date 10/22/1982
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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