The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Myerson's Permasoft Soft Reline Material.
| Device ID | K933468 |
| 510k Number | K933468 |
| Device Name: | MYERSON'S PERMASOFT SOFT RELINE 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 | 1993-07-16 |
| Decision Date | 1994-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842326102002 | K933468 | 000 |
| D001N8150020 | K933468 | 000 |
| D001N8140050 | K933468 | 000 |
| D001N8140020 | K933468 | 000 |
| D001N8125000 | K933468 | 000 |
| D001N8121000 | K933468 | 000 |
| D001N8120000 | K933468 | 000 |
| D001N8116000 | K933468 | 000 |
| D001N8115000 | K933468 | 000 |
| D001N8114000 | K933468 | 000 |
| D001N8111000 | K933468 | 000 |
| D001N8150030 | K933468 | 000 |
| D001N8150050 | K933468 | 000 |
| D001N8151010 | K933468 | 000 |
| 00842326101999 | K933468 | 000 |
| 00842326101982 | K933468 | 000 |
| 00842326101975 | K933468 | 000 |
| 00842326101968 | K933468 | 000 |
| 00842326101951 | K933468 | 000 |
| D001N8160050 | K933468 | 000 |
| D001N8160020 | K933468 | 000 |
| D001N8151050 | K933468 | 000 |
| D001N8151030 | K933468 | 000 |
| D001N8151020 | K933468 | 000 |
| D001N8110000 | K933468 | 000 |