The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Dialyzer, Model F.m.d 150.
| Device ID | K790001 |
| 510k Number | K790001 |
| Device Name: | DIALYZER, MODEL F.M.D 150 |
| Classification | Dialyzer, Parallel Flow |
| Applicant | HOSPAL MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-02 |
| Decision Date | 1979-03-06 |