510(k) K822618
- Device
- EMERGENCY TRACHEOSTOMY INSTRUMENT SET
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822618
- Product code
- LJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-28
- Date received
- 1982-09-02
- Regulation
- 874.4420
- Classification name
- Tracheotome
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANCIS J KELLEHER
- Address
- 1301 School St. Richmond VA US 23220 23220
FDA Registration Numbers#
- 3005273623
- 1450662
- 8040278
- 2245304
- 3035708926
- 3010536692
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933570 | RESOLUTION(TM) HIP STEM | Wrightmedicaltechnologyinc | 1994-03-07 |
Legacy Summary#
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FDA Review#
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