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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 K963285
Device Name EMS SWISS LITHOCLAST LITHOTRIPTER
Applicant
ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/21/1996
Decision Date 02/13/1997
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
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