FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBCUTANEOUS NEEDLE INFUSION SET
K Number: K082818
·
Decision Dec 23, 2008
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
1
Review Days
89
Basic Information
- Device Name
- SUBCUTANEOUS NEEDLE INFUSION SET
- K Number
- K082818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MARCAL MEDICAL, INC.
- Date Received
- September 25, 2008
- Decision Date
- December 23, 2008
- 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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