The following data is part of a premarket notification filed by Gambro-hospal, Inc. with the FDA for Hemospal Kits A1, A2d, Ao, & A1d.
| Device ID | K901368 |
| 510k Number | K901368 |
| Device Name: | HEMOSPAL KITS A1, A2D, AO, & A1D |
| Classification | Dialyzer, Parallel Flow |
| Applicant | GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-23 |
| Decision Date | 1990-08-02 |