The following data is part of a premarket notification filed by Medegen Medical Manufacturing System with the FDA for Maxplus Tru-swab Positive Displacement Connector.
| Device ID | K051939 |
| 510k Number | K051939 |
| Device Name: | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEGEN MEDICAL MANUFACTURING SYSTEM 930 WANNAMAKER AVENUE Ontario, CA 91761 |
| Contact | Tim Truitt |
| 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 | 2005-07-18 |
| Decision Date | 2005-08-01 |
| Summary: | summary |