FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOSTON BLOOD TRANSFUSION SETS
K Number: K822409
·
Decision Sep 30, 1982
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
5
Review Days
51
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Basic Information
- Device Name
- BOSTON BLOOD TRANSFUSION SETS
- K Number
- K822409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Boston Medical Group
- Date Received
- August 10, 1982
- Decision Date
- September 30, 1982
- 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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Other Clearances by The Boston Medical Group
| K Number | Device Name | ||
|---|---|---|---|
| K822406 | BOSTON SOLUTION INFUSION SETS | Sep 30, 1982 | Substantially Equivalent |
| K822410 | BOSTON BLOOD DONOR SETS | Sep 30, 1982 | Substantially Equivalent |
| K822407 | BOSTON SCALP VEIN INFUSION SETS | Sep 30, 1982 | Substantially Equivalent |
| K822408 | BOSTON INFUSION SETS | Sep 30, 1982 | Substantially Equivalent |