The following data is part of a premarket notification filed by Remel Co. with the FDA for Hemastaph.
| Device ID | K840553 |
| 510k Number | K840553 |
| Device Name: | HEMASTAPH |
| Classification | Plasma, Coagulase, Human, Horse And Rabbit |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTL |
| CFR Regulation Number | 866.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-08 |
| Decision Date | 1984-04-13 |