The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Luer Access Injection Site.
| Device ID | K010279 |
| 510k Number | K010279 |
| Device Name: | MEDISYSTEMS LUER ACCESS INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 Seattle, WA 98101 -3016 |
| Contact | Karen Krstulich |
| Correspondent | Karen Krstulich MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 Seattle, WA 98101 -3016 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-30 |
| Decision Date | 2001-05-29 |