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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K855123
Device Name KMW HIP PROSTHESIS POROUS COATED
Applicant
Kirkschner Medical Corp.
10 W. Aylesbury Rd.,
P.O. Box 218
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirkschner Medical Corp.
10 W. Aylesbury Rd.,
P.O. Box 218
Timonium,  MD  21093
Correspondent Contact SAM SON
Date Received12/23/1985
Decision Date 02/11/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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