510(k) K873742
K873742 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES". The FDA issued a decision of Substantially Equivalent on October 1, 1987. The device falls under product code NWA (Prosthesis, Tracheal, Preformed/Molded), a Class II device regulated under 21 CFR 878.3720. Hood Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1987
- Date Received
- September 16, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Preformed/Molded
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type
The device is intended to provide support to weakened or constricting airway walls.