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 |