The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Shelly Protected Av Fistula Needle.
| Device ID | K993187 |
| 510k Number | K993187 |
| Device Name: | SHELLY PROTECTED AV FISTULA NEEDLE |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 1999-11-05 |