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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K912641
Device Name BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact SERAFIN JR
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact SERAFIN JR
Regulation Number888.3353
Classification Product Code
LZO  
Date Received06/14/1991
Decision Date 11/27/1991
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
Recalls CDRH Recalls
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