The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel Injection Plug With Cap.
| Device ID | K011405 |
| 510k Number | K011405 |
| Device Name: | EXEL INJECTION PLUG WITH CAP |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-08 |
| Decision Date | 2001-09-27 |