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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 K844486
Device Name MECRON MRC-HEADLESS FEMORAL COMPONENT
Applicant
Mecron Medical Products, Inc.
2049 Century Park E. #1200
Two Century Plz.
Los Angeles,  CA  90067
Applicant Contact JAY H GELLER
Correspondent
Mecron Medical Products, Inc.
2049 Century Park E. #1200
Two Century Plz.
Los Angeles,  CA  90067
Correspondent Contact JAY H GELLER
Regulation Number888.3360
Classification Product Code
KWL  
Date Received11/19/1984
Decision Date 02/19/1985
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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