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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 K130368
Device Name AUTOLITH TOUCH; URO TOUCH
Applicant
NORTHGATE TECHNOLOGIES INC.
1591 SCOTTSDALE COURT
ELGIN,  IL  60123
Applicant Contact CASEY KUREK
Correspondent
NORTHGATE TECHNOLOGIES INC.
1591 SCOTTSDALE COURT
ELGIN,  IL  60123
Correspondent Contact CASEY KUREK
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/14/2013
Decision Date 11/15/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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