The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Quickset Bloodlines.
| Device ID | K063290 |
| 510k Number | K063290 |
| Device Name: | GAMBRO QUICKSET BLOODLINES |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-01-30 |
| Summary: | summary |