The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Hepcon/system Four & Four P.
| Device ID | K820410 |
| 510k Number | K820410 |
| Device Name: | HEMOTEC HEPCON/SYSTEM FOUR & FOUR P |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | HEMOTEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-12 |
| Decision Date | 1982-04-09 |