The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Rp-610 Parallel Plate Dialyzer.
Device ID | K790827 |
510k Number | K790827 |
Device Name: | RP-610 PARALLEL PLATE DIALYZER |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-20 |
Decision Date | 1979-09-04 |