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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 K955385
Device Name JOHNSON & JOHNSON AUSTIN MOORE STEM
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact SIGALIT CARON
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact SIGALIT CARON
Regulation Number888.3360
Classification Product Code
KWL  
Date Received11/24/1995
Decision Date 01/30/1996
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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