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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 K953924
Device Name XLS-300 XENON LIGHT SOURCE
Applicant
Specialties of Surgery
P.O. Box 560
Jenks,  OK  74037
Applicant Contact JOHN NORTON
Correspondent
Specialties of Surgery
P.O. Box 560
Jenks,  OK  74037
Correspondent Contact JOHN NORTON
Regulation Number876.1500
Classification Product Code
GCT  
Date Received08/18/1995
Decision Date 09/21/1995
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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