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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 K202813
Device Name URO-TOUCH 9 French Probe
Applicant
Northgate Technologies, Inc.
1591 Scottsdale Court
Elgin,  IL  60123
Applicant Contact Todd Gatto
Correspondent
Northgate Technologies, Inc.
1591 Scottsdale Court
Elgin,  IL  60123
Correspondent Contact Todd Gatto
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/24/2020
Decision Date 06/14/2021
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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