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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 K922500
Device Name PSL TOTAL HIP REPLACEMENT SYSTEM
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact AL LIPPINCOTT
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received05/27/1992
Decision Date 01/07/1994
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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