The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Zyno Medical Administration Set.
| Device ID | K132841 |
| 510k Number | K132841 |
| Device Name: | ZYNO MEDICAL ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Contact | Mei Zhang, Phd |
| Correspondent | Mei Zhang, Phd ZYNO MEDICAL LLC 177 PINE ST Natick, MA 01760 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2014-01-23 |
| Summary: | summary |