The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Atmos Ent Cabinet Practica 2.
Device ID | K791936 |
510k Number | K791936 |
Device Name: | ATMOS ENT CABINET PRACTICA 2 |
Classification | Unit, Examining/treatment, Ent |
Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETF |
CFR Regulation Number | 874.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-27 |
Decision Date | 1979-10-30 |