TRACHEOSTOMY CARE KIT
FDA 510(k) clearance K921281 · decided 1992-08-27
Clearance details
- K-number
- K921281
- Device name
- TRACHEOSTOMY CARE KIT
- Applicant
- Trinity Laboratories, Inc.
- Decision
- Unknown
- Date received
- 1992-03-17
- Decision date
- 1992-08-27
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salisbury, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.