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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
510(k) Number K053094
Device Name ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
Applicant
Advanced Bio-Surfaces, Inc.
5909 Baker Rd.
Suite 550
Minneapolis,  MN  55345
Applicant Contact PHILLIP B JARVI
Correspondent
Advanced Bio-Surfaces, Inc.
5909 Baker Rd.
Suite 550
Minneapolis,  MN  55345
Correspondent Contact PHILLIP B JARVI
Regulation Number888.3590
Classification Product Code
HSH  
Date Received11/03/2005
Decision Date 02/06/2006
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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