FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BELZER UW-CSS
K Number: K883782
·
Decision Apr 20, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
18
Applicant Total
1
Review Days
226
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Basic Information
- Device Name
- BELZER UW-CSS
- K Number
- K883782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Du Pont Critical Care
- Date Received
- September 6, 1988
- Decision Date
- April 20, 1989
- Product Code
- KDL
- 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 |
|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | FDA class 2 | Gastroenterology, Urology |
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