The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Adjustable Pharyngeal Airway/berman Iii.
Device ID | K832471 |
510k Number | K832471 |
Device Name: | ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III |
Classification | Airway, Oropharyngeal, Anesthesiology |
Applicant | INMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAE |
CFR Regulation Number | 868.5110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-26 |
Decision Date | 1983-09-12 |