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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 K822644
Device Name RIWOLITH 2135
Applicant
R. Wolf Medical Instruments Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
R. Wolf Medical Instruments Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/01/1982
Decision Date 09/21/1982
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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