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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K913487
Device Name RIWOLITH 2280
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact ROBERT L CASARSA
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact ROBERT L CASARSA
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/06/1991
Decision Date 02/05/1992
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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