510(k) K926073
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1995
- Date Received
- December 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type