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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10020221265382 | K011405 | 000 |
20020221265396 | K011405 | 000 |