FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
K Number: K822775
·
Decision Nov 3, 1982
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
76
Review Days
50
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Basic Information
- Device Name
- INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
- K Number
- K822775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- September 14, 1982
- Decision Date
- November 3, 1982
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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