The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Fistulok Fistula Needle Protection.
| Device ID | K010958 |
| 510k Number | K010958 |
| Device Name: | FISTULOK FISTULA NEEDLE PROTECTION |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
| Contact | Monica Abeles |
| Correspondent | Monica Abeles DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-30 |
| Decision Date | 2001-05-18 |