The following data is part of a premarket notification filed by Espe Gmbh & Co. Kg. with the FDA for Permadyne Garant 2:1.
| Device ID | K953374 |
| 510k Number | K953374 |
| Device Name: | PERMADYNE GARANT 2:1 |
| Classification | Material, Impression |
| Applicant | ESPE GMBH & CO. KG. AM GRIESBERG 2 Seefeld, DE D-82229 |
| Contact | Barbara Wagner |
| Correspondent | Barbara Wagner 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 | 1995-07-18 |
| Decision Date | 1995-08-18 |