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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 K990341
Device Name ELECTRO MECHANICAL LITHOTRIPTOR
Applicant
Northgate Technologies, Inc.
600 Church Rd.
Elgin,  IL  60123
Applicant Contact CASSY KUREK
Correspondent
Northgate Technologies, Inc.
600 Church Rd.
Elgin,  IL  60123
Correspondent Contact CASSY KUREK
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/03/1999
Decision Date 07/14/1999
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
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