MONTGOMERY SILICONE TRACHEAL T-TUBE
FDA 510(k) clearance K810978 · decided 1981-05-05
Clearance details
- K-number
- K810978
- Device name
- MONTGOMERY SILICONE TRACHEAL T-TUBE
- Applicant
- Boston Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-10
- Decision date
- 1981-05-05
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.