The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Airways & Nasopharyngeal Type.
Device ID | K830983 |
510k Number | K830983 |
Device Name: | AIRWAYS & NASOPHARYNGEAL TYPE |
Classification | Airway, Nasopharyngeal |
Applicant | MEDOVATIONS, INC. 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 | 1983-03-29 |
Decision Date | 1983-05-09 |