FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASSIST HEADER CLEANER
K Number: K043126
·
Decision Feb 3, 2005
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
56
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- ASSIST HEADER CLEANER
- K Number
- K043126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcavis International, Inc.
- Date Received
- November 12, 2004
- Decision Date
- February 3, 2005
- Product Code
- LIF
- 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | FDA class 2 | Gastroenterology, Urology |
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