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 |