The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel Huber Infusion Set With Needleless Injection Site.
| Device ID | K012879 |
| 510k Number | K012879 |
| Device Name: | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE |
| 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 | 2001-08-28 |
| Decision Date | 2002-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221078593 | K012879 | 000 |
| 10020221078418 | K012879 | 000 |
| 10020221078449 | K012879 | 000 |
| 10020221078456 | K012879 | 000 |
| 10020221078463 | K012879 | 000 |
| 10020221078487 | K012879 | 000 |
| 10020221078494 | K012879 | 000 |
| 10020221078500 | K012879 | 000 |
| 10020221078548 | K012879 | 000 |
| 10020221078555 | K012879 | 000 |
| 10020221078562 | K012879 | 000 |
| 10020221078586 | K012879 | 000 |
| 10020221078401 | K012879 | 000 |