The following data is part of a premarket notification filed by Gambro-hospal, Inc. with the FDA for Bsm/21&22 Sc Blood Safe Mod & V.p.m. Ven Press Mod.
| Device ID | K902588 |
| 510k Number | K902588 |
| Device Name: | BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1991-03-07 |