FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UMBILI-CATH CATHETER
K Number: K802414
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
4
Review Days
20
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Basic Information
- Device Name
- UMBILI-CATH CATHETER
- K Number
- K802414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Int'L Corp.
- Date Received
- October 3, 1980
- Decision Date
- October 23, 1980
- Product Code
- FOS
- 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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | FDA class 2 | General Hospital |
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