FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBE DECLOGGER
K Number: K905164
·
Decision Feb 13, 1991
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
1
Review Days
89
Basic Information
- Device Name
- TUBE DECLOGGER
- K Number
- K905164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- NOVA DESIGN TECHNOLOGIES, LTD.
- Date Received
- November 16, 1990
- Decision Date
- February 13, 1991
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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