The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Granulyte Powder Dialysate Concentrate And Mixing.
Device ID | K911459 |
510k Number | K911459 |
Device Name: | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING |
Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
Contact | Tom Folden |
Correspondent | Tom Folden FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
Product Code | KPO |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-03 |
Decision Date | 1991-07-17 |