The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Exp 600 Parallel Plate Dialyzer.
Device ID | K811440 |
510k Number | K811440 |
Device Name: | EXP 600 PARALLEL PLATE DIALYZER |
Classification | Dialyzer, Parallel Flow |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJG |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-22 |
Decision Date | 1981-06-12 |