The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Laryngeal Syringe.
Device ID | K822185 |
510k Number | K822185 |
Device Name: | LARYNGEAL SYRINGE |
Classification | Syringe, Piston |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-23 |
Decision Date | 1982-10-18 |