510(k) K952401
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1995
- Date Received
- May 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Emergency Airway
- Device Class
- Class II
- Regulation Number
- 868.5090
- Review Panel
- AN
- Submission Type