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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/Polymer, Cemented Or Uncemented
510(k) Number K893872
Device Name P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact MARSHA STONE
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact MARSHA STONE
Regulation Number888.3390
Classification Product Code
KWY  
Date Received05/26/1989
Decision Date 09/11/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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