The following data is part of a premarket notification filed by North, Inc. with the FDA for Tri-flow Three Way Stopcock.
| Device ID | K961982 |
| 510k Number | K961982 |
| Device Name: | TRI-FLOW THREE WAY STOPCOCK |
| Classification | Stopcock, I.v. Set |
| Applicant | NORTH, INC. 303 WASHINGTON, SUITE B Northfield, MN 55057 |
| Contact | Jim Pokorney |
| Correspondent | Jim Pokorney NORTH, INC. 303 WASHINGTON, SUITE B Northfield, MN 55057 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1997-02-21 |
| Summary: | summary |