The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Fiber Hemofilters Fh55-fh77 & 88.
| Device ID | K840720 |
| 510k Number | K840720 |
| Device Name: | FIBER HEMOFILTERS FH55-FH77 & 88 |
| Classification | Airbrush |
| Applicant | GAMBRO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-17 |
| Decision Date | 1984-04-24 |