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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 K962024
Device Name S-57 VIDEO IMAGING SYSTEM
Applicant
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Applicant Contact KARL J WEYDIG
Correspondent
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Correspondent Contact KARL J WEYDIG
Regulation Number876.1500
Classification Product Code
FET  
Date Received05/23/1996
Decision Date 07/09/1996
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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