The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Cuffed Linder Nasotracheal Airway.
| Device ID | K900457 |
| 510k Number | K900457 |
| Device Name: | CUFFED LINDER NASOTRACHEAL AIRWAY |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Contact | Linder, Md |
| Correspondent | Linder, Md POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-04-16 |