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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, Biodegradable, Soft Tissue
510(k) Number K990340
Device Name ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
Applicant
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Applicant Contact VERNON C BROWN
Correspondent
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Correspondent Contact VERNON C BROWN
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received02/03/1999
Decision Date 01/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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