510(k) K033189
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2004
- Date Received
- October 1, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway, Oropharyngeal, Anesthesiology
- Device Class
- Class I
- Regulation Number
- 868.5110
- Review Panel
- AN
- Submission Type