FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
K Number: K073339
·
Decision Mar 3, 2008
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
3
Review Days
96
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Basic Information
- Device Name
- BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
- K Number
- K073339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fenwal, Inc.
- Date Received
- November 28, 2007
- Decision Date
- March 3, 2008
- Product Code
- BRZ
- 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 |
|---|---|---|---|
| BRZ | Set, Blood Transfusion | FDA class 2 | General Hospital |
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