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 |