The following data is part of a premarket notification filed by Medex, Inc. with the FDA for 3-way Stopcock.
| Device ID | K782168 |
| 510k Number | K782168 |
| Device Name: | 3-WAY STOPCOCK |
| Classification | Stopcock, I.v. Set |
| Applicant | MEDEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-29 |
| Decision Date | 1979-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688505369 | K782168 | 000 |
| 50351688508230 | K782168 | 000 |
| 50351688508223 | K782168 | 000 |
| 50351688508216 | K782168 | 000 |