510(k) K955520
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1996
- Date Received
- December 4, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valve, Non-Rebreathing
- Device Class
- Class II
- Regulation Number
- 868.5870
- Review Panel
- AN
- Submission Type