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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, Hemi-, Femoral, Metal
510(k) Number K895886
Device Name BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL 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 Number888.3360
Classification Product Code
KWL  
Date Received10/05/1989
Decision Date 12/01/1989
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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