The following data is part of a premarket notification filed by One Stick Llc with the FDA for One Stick Y Extension Set And Volumeter.
| Device ID | K060672 |
| 510k Number | K060672 |
| Device Name: | ONE STICK Y EXTENSION SET AND VOLUMETER |
| Classification | Set, Administration, Intravascular |
| Applicant | ONE STICK LLC P.O. BOX 3575 Lubbock, TX 79452 -3575 |
| Contact | Tracy Magee |
| 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 | 2006-03-14 |
| Decision Date | 2006-03-31 |
| Summary: | summary |