EMERGENCY TRACHEOSTOMY KIT
FDA 510(k) clearance K823872 · decided 1983-01-21
Clearance details
- K-number
- K823872
- Device name
- EMERGENCY TRACHEOSTOMY KIT
- Applicant
- Omnicon Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-27
- Decision date
- 1983-01-21
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- EWC
- Device class
- 1
- Regulation number
- 874.1060
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING (K822269) | Kelleher Corp. | 1982-09-09 |
Recalls involving this device
No recalls on record reference this clearance.