The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Position Penta, Position Penta Quick.
| Device ID | K974231 |
| 510k Number | K974231 |
| Device Name: | POSITION PENTA, POSITION PENTA QUICK |
| Classification | Material, Impression |
| Applicant | ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Contact | Barbara Wagner-schuh |
| Correspondent | Barbara Wagner-schuh ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-01-29 |
| Summary: | summary |