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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K905124
Device Name MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE
Applicant
Red Wing Imaging, Inc.
18 R. F. Higgins Dr.
Norwell,  MA  02061
Applicant Contact ROBERT L KANE
Correspondent
Red Wing Imaging, Inc.
18 R. F. Higgins Dr.
Norwell,  MA  02061
Correspondent Contact ROBERT L KANE
Regulation Number876.1500
Classification Product Code
GCT  
Date Received11/14/1990
Decision Date 01/25/1991
Decision Substantially Equivalent (SESE)
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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