The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel I.v. Administration Set.
| Device ID | K010404 |
| 510k Number | K010404 |
| Device Name: | EXEL I.V. ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EXELINT INTL. CO. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTL. CO. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221290889 | K010404 | 000 |
| 10020221290865 | K010404 | 000 |
| 00020221290851 | K010404 | 000 |
| 10020221290834 | K010404 | 000 |
| 00020221290820 | K010404 | 000 |
| 10020221290810 | K010404 | 000 |
| 10020221270867 | K010404 | 000 |