The following data is part of a premarket notification filed by Selomas, Inc. with the FDA for Vitofit.
| Device ID | K821260 |
| 510k Number | K821260 |
| Device Name: | VITOFIT |
| Classification | Stocking, Medical Support (for General Medical Purposes) |
| Applicant | SELOMAS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-30 |
| Decision Date | 1982-06-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITOFIT 73427959 1290230 Dead/Cancelled |
Delta Vertriebs-GmbH 1983-05-27 |