FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FREHAN INC. I.V. FILTER HOLDER
K Number: K830300
·
Decision Mar 1, 1983
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
2
Review Days
32
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Basic Information
- Device Name
- FREHAN INC. I.V. FILTER HOLDER
- K Number
- K830300
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Saxnor Corp.
- Date Received
- January 28, 1983
- Decision Date
- March 1, 1983
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
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Other Clearances by Saxnor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832300 | I.V. FILTER HOLDER | Oct 4, 1983 | Substantially Equivalent |