The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Monitral.
Device ID | K830595 |
510k Number | K830595 |
Device Name: | MONITRAL |
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 | 1983-02-24 |
Decision Date | 1983-04-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MONITRAL 73560532 1408354 Dead/Cancelled |
HOSPAL LTD. 1985-09-27 |