FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K Number: K970653
·
Decision Mar 11, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
505
Review Days
383
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Basic Information
- Device Name
- CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K Number
- K970653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- February 21, 1997
- Decision Date
- March 11, 1998
- Product Code
- MSF
- 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 |
|---|---|---|---|
| MSF | Hemodialyzer, Re-Use, High Flux | FDA class 2 | Gastroenterology, Urology |
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