The following data is part of a premarket notification filed by Porex Medical Products with the FDA for Nac Plus Needleless Access Connector.
| Device ID | K011193 |
| 510k Number | K011193 |
| Device Name: | NAC PLUS NEEDLELESS ACCESS CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | POREX MEDICAL PRODUCTS 930 WANAMAKER Ontario, CA 91761 |
| Contact | Tim Truitt |
| Correspondent | Tim Truitt POREX MEDICAL PRODUCTS 930 WANAMAKER Ontario, CA 91761 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-06-12 |