The following data is part of a premarket notification filed by Exelint International Co. with the FDA for A.v. Fistula Needle.
| Device ID | K001496 |
| 510k Number | K001496 |
| Device Name: | A.V. FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90231 -3194 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90231 -3194 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2000-08-01 |