The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Nagashima Sft-ii Laryngoscope Straight.
Device ID | K821707 |
510k Number | K821707 |
Device Name: | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT |
Classification | Laryngoscope, Nasopharyngoscope |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EQN |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-09 |
Decision Date | 1982-06-25 |