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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 K951356
Device Name VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED
Applicant
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact MARC F MALOOLEY
Correspondent
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact MARC F MALOOLEY
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
HSX   JDI   JWH  
Date Received03/24/1995
Decision Date 06/19/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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