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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K062720
Device Name S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
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
FJL  
Subsequent Product Codes
FAS   FDC  
Date Received09/12/2006
Decision Date 03/22/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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