The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Impregum-f.
| Device ID | K853529 |
| 510k Number | K853529 |
| Device Name: | IMPREGUM-F |
| Classification | Material, Impression |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold A Opotow |
| Correspondent | Harold A Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1986-03-17 |