TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
FDA 510(k) clearance K051587 · decided 2005-10-25
Clearance details
- K-number
- K051587
- Device name
- TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
- Applicant
- Tracoe Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-06-15
- Decision date
- 2005-10-25
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Westborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.