The following data is part of a premarket notification filed by Infusion Innovations, Inc. with the FDA for Q-flo Closed Male Luer Connector.
| Device ID | K121554 |
| 510k Number | K121554 |
| Device Name: | Q-FLO CLOSED MALE LUER CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | INFUSION INNOVATIONS, INC. 7514 GIRARD AVENUE Lajolla, CA 92037 |
| Contact | Babak Nemati |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-25 |
| Decision Date | 2012-06-08 |
| Summary: | summary |