MIDAS GOLD ELECTROFORMING SYSTEM

Alloy, Gold-based Noble Metal

AUSTENAL, INC.

The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Midas Gold Electroforming System.

Pre-market Notification Details

Device IDK955509
510k NumberK955509
Device Name:MIDAS GOLD ELECTROFORMING SYSTEM
ClassificationAlloy, Gold-based Noble Metal
Applicant AUSTENAL, INC. 4101 WEST 51ST ST. Chicago,  IL  60632 -4287
ContactRonald P Dudek
CorrespondentRonald P Dudek
AUSTENAL, INC. 4101 WEST 51ST ST. Chicago,  IL  60632 -4287
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-04
Decision Date1995-12-28

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