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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K954213
Device Name ATH FULL PROFILE ACETABULAR CUP SYSTEM
Applicant
Kinamed, Inc.
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact JOEL SLOMOFF
Correspondent
Kinamed, Inc.
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact JOEL SLOMOFF
Regulation Number888.3358
Classification Product Code
LPH  
Date Received09/07/1995
Decision Date 10/25/1995
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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