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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, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
510(k) Number K853730
Device Name FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
Applicant
Protek, Inc.
2601 Fortune Cir. E. Suite 105b
2601 Fortune Cir. E. Suite 105b
Indianapolis,  IN  46241
Applicant Contact KENNETH EPLING
Correspondent
Protek, Inc.
2601 Fortune Cir. E. Suite 105b
2601 Fortune Cir. E. Suite 105b
Indianapolis,  IN  46241
Correspondent Contact KENNETH EPLING
Regulation Number888.3560
Classification Product Code
MBV  
Date Received09/06/1985
Decision Date 02/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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