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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K012309
Device Name RIWO SYSTEM TRAYS
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
FEB  
Subsequent Product Code
KCT  
Date Received07/23/2001
Decision Date 10/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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