The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Single Patient Systems.
Device ID | K780682 |
510k Number | K780682 |
Device Name: | SINGLE PATIENT SYSTEMS |
Classification | System, Dialysate Delivery, Single Patient |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKP |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-24 |
Decision Date | 1978-06-22 |