FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KNOTT NG TUBE
K Number: K971354
·
Decision Nov 19, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
12
Applicant Total
2
Review Days
222
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Basic Information
- Device Name
- KNOTT NG TUBE
- K Number
- K971354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Michael M. Knott, M.D.
- Date Received
- April 11, 1997
- Decision Date
- November 19, 1997
- Product Code
- FEG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Michael M. Knott, M.D.
| K Number | Device Name | ||
|---|---|---|---|
| K981966 | NOSEBLEED NOSECLIP | Aug 14, 1998 | Substantially Equivalent |