FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
K Number: K051264
·
Decision Sep 1, 2005
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
108
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Basic Information
- Device Name
- COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
- K Number
- K051264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unomedical A/S
- Date Received
- May 16, 2005
- Decision Date
- September 1, 2005
- 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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