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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 K952696
Device Name XENON LIGHT SOURCE MODEL 5121
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Applicant Contact ROBERT L CASARSA
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact ROBERT L CASARSA
Regulation Number876.1500
Classification Product Code
GCT  
Date Received06/13/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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