Bibag
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Bibag.
Pre-market Notification Details
| Device ID | K162716 |
| 510k Number | K162716 |
| Device Name: | Bibag |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham, MA 02451 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2017-05-18 |
Trademark Results [Bibag]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIBAG 77473835 4132148 Live/Registered |
Fresenius Medical Care Holdings, Inc. 2008-05-14 |
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