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 | K831029 |
510k Number | K831029 |
Device Name: | HEMOPERFUSION SYSTEM TP-400 |
Classification | Apparatus, Hemoperfusion, Sorbent |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLD |
CFR Regulation Number | 876.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-30 |
Decision Date | 1983-08-26 |