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 |