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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resectoscope
510(k) Number K191341
Device Name Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Applicant
Corinth MedTech, Inc.
1601 S. De Anza Blvd, Suite 200
Cupertino,  CA  95014
Applicant Contact Sandeep Saboo
Correspondent
Corinth MedTech, Inc.
1601 S. De Anza Blvd, Suite 200
Cupertino,  CA  95014
Correspondent Contact Sandeep Saboo
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
GEI   KQT  
Date Received05/20/2019
Decision Date 06/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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