P.M. HIP-FEMORAL PROSTHESIS

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

ADVANCED BIOSEARCH ASSN.

The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for P.m. Hip-femoral Prosthesis.

Pre-market Notification Details

Device IDK853916
510k NumberK853916
Device Name:P.M. HIP-FEMORAL PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville,  CA  94506 -4617
ContactBarry M Calvarese
CorrespondentBarry M Calvarese
ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville,  CA  94506 -4617
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-23
Decision Date1985-12-27

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