510(k) K971354
K971354 is an FDA 510(k) premarket notification submitted by Michael M. Knott, M.D. for the device "KNOTT NG TUBE". The FDA issued a decision of Substantially Equivalent on November 19, 1997. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Michael M. Knott, M.D. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1997
- Date Received
- April 11, 1997
- 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