The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Gambro Fh 22h Fiber Hemofltr/prisma Fh 22h Blood Tubing/hemofltr Set.
| Device ID | K955497 |
| 510k Number | K955497 |
| Device Name: | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | COBE RENAL CARE, INC. 4503 MOORLAND AVE. Minneapolis, MN 55424 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman COBE RENAL CARE, INC. 4503 MOORLAND AVE. Minneapolis, MN 55424 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1997-09-25 |