The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Nasopharyngeal Airways.
Device ID | K841093 |
510k Number | K841093 |
Device Name: | NASOPHARYNGEAL AIRWAYS |
Classification | Airway, Nasopharyngeal |
Applicant | INMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTQ |
CFR Regulation Number | 868.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-13 |
Decision Date | 1984-03-23 |