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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 K923822
Device Name AUTOLITH-IEHL
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact KENNETH J SIKORA
Correspondent
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact KENNETH J SIKORA
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/30/1992
Decision Date 01/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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