The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Emergency Tracheostomy Instrument Set.
| Device ID | K822618 |
| 510k Number | K822618 |
| Device Name: | EMERGENCY TRACHEOSTOMY INSTRUMENT SET |
| Classification | Tracheotome |
| Applicant | KELLEHER CORP. 1301 SCHOOL STREET Richmond , VA 23220 - |
| Contact | Francis J Kelleher |
| Correspondent | Francis J Kelleher KELLEHER CORP. 1301 SCHOOL STREET Richmond , VA 23220 - |
| Product Code | LJW |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-02 |
| Decision Date | 1983-01-28 |