510(k) K994300
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2000
- Date Received
- December 21, 1999
- 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