The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Shelly Protected Av Fistula Needle.
| Device ID | K992653 |
| 510k Number | K992653 |
| Device Name: | SHELLY PROTECTED AV FISTULA NEEDLE |
| Classification | Needle, Fistula |
| 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 | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 1999-10-27 |