FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCONCENTRATOR KIT
K Number: K850979
·
Decision Jul 29, 1985
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
4
Review Days
143
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Basic Information
- Device Name
- HEMOCONCENTRATOR KIT
- K Number
- K850979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Omnis Surgical, Inc.
- Date Received
- March 8, 1985
- Decision Date
- July 29, 1985
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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