The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Parallel Plate Dialyzer Holder.
Device ID | K811292 |
510k Number | K811292 |
Device Name: | PARALLEL PLATE DIALYZER HOLDER |
Classification | Set, Dialyzer Holder |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-11 |
Decision Date | 1981-06-02 |