The following data is part of a premarket notification filed by National Medical Technology with the FDA for Dualume Laryngeal Examination Telescope.
Device ID | K790845 |
510k Number | K790845 |
Device Name: | DUALUME LARYNGEAL EXAMINATION TELESCOPE |
Classification | Telescope, Laryngeal-bronchial |
Applicant | NATIONAL MEDICAL TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ENZ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-04 |
Decision Date | 1979-07-24 |