The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Cardioflow 100 Hemoconcentrator/preparation Kit.
Device ID | K883307 |
510k Number | K883307 |
Device Name: | CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
Contact | Catherina Madormo |
Correspondent | Catherina Madormo HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-04 |
Decision Date | 1988-10-12 |