The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Therapeutic Exchange System.
| Device ID | K831423 |
| 510k Number | K831423 |
| Device Name: | THERAPEUTIC EXCHANGE SYSTEM |
| Classification | Columns, Immunoadsorption In Extracorporeal Systems |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LQQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-03 |
| Decision Date | 1984-01-03 |