The following data is part of a premarket notification filed by Harleco with the FDA for Calcium Set, Item No. 65004.
| Device ID | K771928 |
| 510k Number | K771928 |
| Device Name: | CALCIUM SET, ITEM NO. 65004 |
| Classification | Azo Dye, Calcium |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-14 |
| Decision Date | 1977-11-14 |