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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K003757
Device Name THERMOFX MESH
Applicant
Bionx Implants, Ltd.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
Bionx Implants, Ltd.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/06/2000
Decision Date 02/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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