The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Filtral Tm 20 Hemodialyzer/filter.
Device ID | K893742 |
510k Number | K893742 |
Device Name: | FILTRAL TM 20 HEMODIALYZER/FILTER |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
Contact | Jo Lang |
Correspondent | Jo Lang HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-17 |
Decision Date | 1989-07-24 |