The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set.
Device ID | K982760 |
510k Number | K982760 |
Device Name: | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
Contact | William M Townsend |
Correspondent | William M Townsend GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-06 |
Decision Date | 1998-11-04 |