The following data is part of a premarket notification filed by Medegen Medical Manufacturing Services, Inc. with the FDA for Modification To The Nac Plus Needleless Access Connector.
| Device ID | K041179 |
| 510k Number | K041179 |
| Device Name: | MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. 930 WANAMAKER Ontario, CA 91761 -8151 |
| Contact | Tim Truitt |
| Correspondent | Tim Truitt MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. 930 WANAMAKER Ontario, CA 91761 -8151 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-06-04 |