The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Midas Gold Electroforming System.
Device ID | K955509 |
510k Number | K955509 |
Device Name: | MIDAS GOLD ELECTROFORMING SYSTEM |
Classification | Alloy, Gold-based Noble Metal |
Applicant | AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
Contact | Ronald P Dudek |
Correspondent | Ronald P Dudek AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-04 |
Decision Date | 1995-12-28 |