FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
K Number: K853413
·
Decision Sep 6, 1985
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
56
Applicant Total
4
Review Days
23
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Basic Information
- Device Name
- RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
- K Number
- K853413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Alcide Corp.
- Date Received
- August 14, 1985
- Decision Date
- September 6, 1985
- 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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