The following data is part of a premarket notification filed by New Cos Inc. with the FDA for Patient-specific Airway Stent.
| Device ID | K182743 |
| 510k Number | K182743 |
| Device Name: | Patient-Specific Airway Stent |
| Classification | Prosthesis, Tracheal, Preformed/molded |
| Applicant | New Cos Inc. 7100 Euclid Ave, Ste 180 Cleveland, OH 44103 |
| Contact | Keith Grafmeyer |
| Correspondent | Keith Grafmeyer New Cos Inc. 7100 Euclid Ave, Ste 180 Cleveland, OH 44103 |
| Product Code | NWA |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-10-23 |
| Summary: | summary |