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 |