The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Three-way Stopcock.
| Device ID | K172266 |
| 510k Number | K172266 |
| Device Name: | Dynarex Three-Way Stopcock |
| Classification | Stopcock, I.v. Set |
| Applicant | Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10962 |
| Contact | Pablo Martinez |
| Correspondent | Pablo Martinez Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10962 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-27 |
| Decision Date | 2018-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784705736 | K172266 | 000 |