The following data is part of a premarket notification filed by Renal Devices, Inc. with the FDA for Hemophron.
Device ID | K810612 |
510k Number | K810612 |
Device Name: | HEMOPHRON |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | RENAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-06 |
Decision Date | 1981-04-29 |