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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arthroscope
510(k) Number K203526
Device Name C Scope Visualization System
Applicant
CIT Ortho
26202 Detroit Road Ste 340
Westlake,  OH  44145
Applicant Contact Megan Lecavalier
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/02/2020
Decision Date 01/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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