The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Linder Nasotracheal Airway.
| Device ID | K881496 |
| 510k Number | K881496 |
| Device Name: | LINDER NASOTRACHEAL AIRWAY |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | POLAMEDCO, INC. 1625 17TH ST. Santa Monica, CA 90404 |
| Contact | Linder, Md |
| Correspondent | Linder, Md POLAMEDCO, INC. 1625 17TH ST. Santa Monica, CA 90404 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-05-31 |