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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K191811
Device Name Catalyst OrthoScience CSR Shoulder System
Applicant
Catalyst Orthoscience, Inc.
14710 Tamiami Trl., N.
Suite 102
Naples,  FL  34110
Applicant Contact Dale Davison
Correspondent
Catalyst Orthoscience, Inc.
14710 Tamiami Trl., N.
Suite 102
Naples,  FL  34110
Correspondent Contact Dale Davison
Regulation Number888.3650
Classification Product Code
KWT  
Date Received07/05/2019
Decision Date 09/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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