The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Hemodialysis System And Accessory.
| Device ID | K902426 |
| 510k Number | K902426 |
| Device Name: | HEMODIALYSIS SYSTEM AND ACCESSORY |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Contact | Mark Gainor |
| Correspondent | Mark Gainor GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-31 |
| Decision Date | 1990-11-20 |