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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 K111058
Device Name URETRON MODEL URT
Applicant
MED-SONICS CORP
5451 MERWIN LANE,
SUITE 203
ERIE,  PA  16510
Applicant Contact WILLIAM A STOLL
Correspondent
MED-SONICS CORP
5451 MERWIN LANE,
SUITE 203
ERIE,  PA  16510
Correspondent Contact WILLIAM A STOLL
Regulation Number876.4480
Classification Product Code
FFK  
Date Received04/18/2011
Decision Date 03/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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