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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 K920410
Device Name EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
Applicant
Psi Medical Products, Inc.
240 Long Hill Cross Rd.
Shelton,  CT  06484
Applicant Contact JOHN SOKOLOWSKI
Correspondent
Psi Medical Products, Inc.
240 Long Hill Cross Rd.
Shelton,  CT  06484
Correspondent Contact JOHN SOKOLOWSKI
Regulation Number876.4480
Classification Product Code
FFK  
Date Received01/31/1992
Decision Date 02/14/1994
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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