510(k) K033720
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2005
- Date Received
- November 26, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vapocoolant Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type