The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Hemoperfusion System Tp-400.
| Device ID | K840532 |
| 510k Number | K840532 |
| Device Name: | HEMOPERFUSION SYSTEM TP-400 |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-05-30 |