SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
FDA 510(k) clearance K844051 · decided 1985-01-18
Clearance details
- K-number
- K844051
- Device name
- SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
- Applicant
- Washington-Greene County Branch Pennsylvania Assoc
- Decision
- Substantially Equivalent
- Date received
- 1984-10-17
- Decision date
- 1985-01-18
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- NXA
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.