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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K041749
Device Name SCANDIUS ACL RECONSTRUCTION SYSTEM
Applicant
Scandius Biomedical, Inc.
11a Beaver Brook Rd.
Littleton,  MA  01460
Applicant Contact ERIC BANNON
Correspondent
Scandius Biomedical, Inc.
11a Beaver Brook Rd.
Littleton,  MA  01460
Correspondent Contact ERIC BANNON
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/29/2004
Decision Date 09/08/2004
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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