The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Needle, Dialysis.
| Device ID | K902564 |
| 510k Number | K902564 |
| Device Name: | NEEDLE, DIALYSIS |
| Classification | Needle, Fistula |
| 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 | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-11 |
| Decision Date | 1991-03-01 |