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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urethrotome
510(k) Number K000905
Device Name URETHROTOME 8667.XXX AND 8670.XXX
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 Number876.4770
Classification Product Code
EZO  
Date Received03/21/2000
Decision Date 05/12/2000
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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