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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, Cemented
510(k) Number K090208
Device Name BIOPRO FEMORAL HEADS
Applicant
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact DAVID MRAK
Correspondent
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact DAVID MRAK
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received01/28/2009
Decision Date 05/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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