FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOCARE 20 MICRON BLOOD FILTER
K Number: K000719
·
Decision May 30, 2000
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- NEOCARE 20 MICRON BLOOD FILTER
- K Number
- K000719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Whatman, Inc.
- Date Received
- March 3, 2000
- Decision Date
- May 30, 2000
- Product Code
- CAK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | FDA class 2 | General Hospital |
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