The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Excel A.v Fisutal Needle Set.
| Device ID | K013037 |
| 510k Number | K013037 |
| Device Name: | EXCEL A.V FISUTAL NEEDLE SET |
| Classification | Needle, Fistula |
| Applicant | EXELINT INTL. CO. 5840 WEST CENTINELA AVE. Los Angeles, CA 90045 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTL. CO. 5840 WEST CENTINELA AVE. Los Angeles, CA 90045 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2001-12-07 |