The following data is part of a premarket notification filed by Premier Medical with the FDA for Premier Die-trak Articulator.
| Device ID | K884418 |
| 510k Number | K884418 |
| Device Name: | PREMIER DIE-TRAK ARTICULATOR |
| Classification | Articulators |
| Applicant | PREMIER MEDICAL 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER MEDICAL 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Product Code | EJP |
| CFR Regulation Number | 872.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1988-11-14 |