EMERGENCY TRACHEOSTOMY INSTRUMENT SET
FDA 510(k) clearance K822618 · decided 1983-01-28
Clearance details
- K-number
- K822618
- Device name
- EMERGENCY TRACHEOSTOMY INSTRUMENT SET
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-02
- Decision date
- 1983-01-28
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- LJW
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Richmond, VA, 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 |
|---|---|---|
| RESOLUTION(TM) HIP STEM (K933570) | Wrightmedicaltechnologyinc | 1994-03-07 |
Recalls involving this device
No recalls on record reference this clearance.