The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Cartridge Blood Sets.
| Device ID | K070414 |
| 510k Number | K070414 |
| Device Name: | GAMBRO CARTRIDGE BLOOD SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 10810 W. 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 | 2007-02-12 |
| Decision Date | 2007-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414112395 | K070414 | 000 |
| 37332414085217 | K070414 | 000 |
| 37332414055180 | K070414 | 000 |
| 37332414046836 | K070414 | 000 |
| 37332414007882 | K070414 | 000 |
| 37332414007868 | K070414 | 000 |
| 37332414007837 | K070414 | 000 |
| 37332414007813 | K070414 | 000 |