510(k) K961711
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1997
- Date Received
- May 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Nasogastric
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type