The following data is part of a premarket notification filed by Rymed Technologies, Llc with the FDA for Encore Neutral.
| Device ID | K162826 |
| 510k Number | K162826 |
| Device Name: | Encore Neutral |
| Classification | Set, Administration, Intravascular |
| Applicant | RyMed Technologies, LLC 6000 W. William Cannon Drive B300 Austin, TX 78749 |
| Contact | Anna Mccutchen |
| Correspondent | Anna Mccutchen RyMed Technologies, LLC 6000 W. William Cannon Drive B300 Austin, TX 78749 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250273735949 | K162826 | 000 |