The following data is part of a premarket notification filed by Zyno Medical Llc with the FDA for Zyno Medical Administration Set.
| Device ID | K120685 |
| 510k Number | K120685 |
| Device Name: | ZYNO MEDICAL ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ZYNO MEDICAL LLC 10 TECH CIRCLE Natick, MA 01760 |
| Contact | Chaoyoung Lee |
| Correspondent | Chaoyoung Lee ZYNO MEDICAL LLC 10 TECH CIRCLE Natick, MA 01760 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-06 |
| Decision Date | 2012-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814371020604 | K120685 | 000 |
| 20814371020383 | K120685 | 000 |
| 20814371020437 | K120685 | 000 |
| 20814371020444 | K120685 | 000 |
| 20814371020451 | K120685 | 000 |
| 20814371020468 | K120685 | 000 |
| 10814371020478 | K120685 | 000 |
| 20814371020482 | K120685 | 000 |
| 20814371020499 | K120685 | 000 |
| 20814371020505 | K120685 | 000 |
| 20814371020512 | K120685 | 000 |
| 20814371020529 | K120685 | 000 |
| 20814371020536 | K120685 | 000 |
| 20814371020543 | K120685 | 000 |
| 20814371020550 | K120685 | 000 |
| 20814371020567 | K120685 | 000 |
| 20814371020574 | K120685 | 000 |
| 20814371020581 | K120685 | 000 |
| 20814371020369 | K120685 | 000 |