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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 K992251
Device Name SWISS LITHOCLAST MULTIPURPOSE PROBE
Applicant
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/06/1999
Decision Date 07/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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