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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K190333
Device Name Paradigm All-Suture Anchor 1.8mm, White/Black #2
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Orjada Dervishleri
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Orjada Dervishleri
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/14/2019
Decision Date 03/18/2019
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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