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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K190113
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 Number884.1690
Classification Product Code
HIH  
Subsequent Product Codes
GEI   HIG  
Date Received01/24/2019
Decision Date 04/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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