The following data is part of a premarket notification filed by Degussa Ag with the FDA for Deguflex Monophase.
| Device ID | K901865 |
| 510k Number | K901865 |
| Device Name: | DEGUFLEX MONOPHASE |
| Classification | Material, Impression |
| Applicant | DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
| Contact | Mackert |
| Correspondent | Mackert DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-09-06 |