VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
FDA 510(k) clearance K853502 · decided 1985-10-01
Clearance details
- K-number
- K853502
- Device name
- VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1985-08-21
- Decision date
- 1985-10-01
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Gary, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.