FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
K Number: K861523
·
Decision May 27, 1986
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
- K Number
- K861523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Jufrey Multimed Corp.
- Date Received
- April 23, 1986
- Decision Date
- May 27, 1986
- 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 |
Similar 510(k) Clearances
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Other Clearances by Jufrey Multimed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K861519 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F) | May 27, 1986 | Substantially Equivalent |
| K861521 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330) | May 27, 1986 | Substantially Equivalent |
| K861520 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205) | May 27, 1986 | Substantially Equivalent |
| K861518 | UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) | May 27, 1986 | Substantially Equivalent |
| K853527 | JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET | Sep 23, 1985 | Substantially Equivalent |
| K853327 | JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION | Aug 21, 1985 | Substantially Equivalent |