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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 K951531
Device Name SWISS LITHOCLAST LITHOTRIPTER
Applicant
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number876.4480
Classification Product Code
FFK  
Date Received04/03/1995
Decision Date 08/24/1995
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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