FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K Number: K950454
·
Decision Apr 27, 1995
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
130
Applicant Total
503
Review Days
83
Basic Information
- Device Name
- CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
- K Number
- K950454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BAXTER HEALTHCARE CORP.
- Date Received
- February 3, 1995
- Decision Date
- April 27, 1995
- Product Code
- FJI
- 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 |
|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | FDA class 2 | Gastroenterology, Urology |
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