FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEEL-FINE INSULIN PEN NEEDLE
K Number: K080904
·
Decision Jun 4, 2008
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
3
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FEEL-FINE INSULIN PEN NEEDLE
- K Number
- K080904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Feel Tech
- Date Received
- April 1, 2008
- Decision Date
- June 4, 2008
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital