The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel I.v. Extension Set.
Device ID | K092172 |
510k Number | K092172 |
Device Name: | EXEL I.V. EXTENSION SET |
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 | 2009-07-21 |
Decision Date | 2010-01-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
01002022117307 | K092172 | 000 |
10020221117209 | K092172 | 000 |
10020221017721 | K092172 | 000 |
10020221017301 | K092172 | 000 |
00020221017205 | K092172 | 000 |
10020221017127 | K092172 | 000 |