The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Hospal Biospal Scu/cavh Kit.
Device ID | K841152 |
510k Number | K841152 |
Device Name: | HOSPAL BIOSPAL SCU/CAVH KIT |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-19 |
Decision Date | 1984-07-06 |