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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 K982139
Device Name BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
Applicant
Bionx Implants, Inc.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JOHNATHAN S KAHAN
Correspondent
Bionx Implants, Inc.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JOHNATHAN S KAHAN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/17/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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