The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Excel Primary Solution Set.
| Device ID | K031500 |
| 510k Number | K031500 |
| Device Name: | EXCEL PRIMARY SOLUTION 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 | 2003-05-13 |
| Decision Date | 2003-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00020221270853 | K031500 | 000 |
| 20020221260858 | K031500 | 000 |