UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
FDA 510(k) clearance K862666 · decided 1986-08-01
Clearance details
- K-number
- K862666
- Device name
- UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1986-07-14
- Decision date
- 1986-08-01
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.