The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro G Series Blood Line Sets For Hem..
| Device ID | K801016 |
| 510k Number | K801016 |
| Device Name: | GAMBRO G SERIES BLOOD LINE SETS FOR HEM. |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-29 |
| Decision Date | 1980-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414048915 | K801016 | 000 |
| 37332414004690 | K801016 | 000 |