P.F.C. TOTAL HIP SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Total Hip System.

Pre-market Notification Details

Device IDK944132
510k NumberK944132
Device Name:P.F.C. TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. BRUNEL WAY SLOUGH, BERKS England,  GB Sl1 Ixr
ContactPatricia Bankert
CorrespondentPatricia Bankert
JOHNSON & JOHNSON PROFESSIONALS, INC. BRUNEL WAY SLOUGH, BERKS England,  GB Sl1 Ixr
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-24
Decision Date1995-01-06

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