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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 K981804
Device Name XENON LIGHT SOURCE MODEL LS6000
Applicant
CONTEC MEDICAL VISION, LTD.
1109 STURBRIDGE RD.
FALLSTON,  MD  21047
Applicant Contact ALBERT E AUSTIN
Correspondent
CONTEC MEDICAL VISION, LTD.
1109 STURBRIDGE RD.
FALLSTON,  MD  21047
Correspondent Contact ALBERT E AUSTIN
Regulation Number876.1500
Classification Product Code
GCT  
Subsequent Product Code
FCW  
Date Received05/21/1998
Decision Date 07/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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