FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOGO-NU-WAY
K Number: K800186
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
1
Review Days
28
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Basic Information
- Device Name
- LOGO-NU-WAY
- K Number
- K800186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gary Giancarlo
- Date Received
- January 29, 1980
- Decision Date
- February 26, 1980
- Product Code
- KNX
- 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
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