The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Myerson's Economy Denture Base Material.
| Device ID | K970522 |
| 510k Number | K970522 |
| Device Name: | MYERSON'S ECONOMY DENTURE BASE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-11 |
| Decision Date | 1997-05-14 |
| Summary: | summary |