SSA HIP PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS

The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Ssa Hip Prosthesis.

Pre-market Notification Details

Device IDK840357
510k NumberK840357
Device Name:SSA HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-26
Decision Date1984-02-17

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