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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 K003970
Device Name CONTOUR LABRAL NAIL, MODEL 533520A
Applicant
Bionx Implants, Inc.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
Bionx Implants, Inc.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MRY  
Date Received12/22/2000
Decision Date 01/12/2001
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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