510(k) K022112
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2003
- Date Received
- June 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type