FDA 510(k) Application Details - K955385

Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal

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510(K) Number K955385
Device Name Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact SIGALIT CARON
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Regulation Number 888.3360

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Classification Product Code KWL
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Date Received 11/24/1995
Decision Date 01/30/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K955385


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