FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K Number: K071785
·
Decision Aug 2, 2007
Classifications
1
FEI Numbers
466
Registration Numbers
466
Same Product Code
680
Applicant Total
38
Review Days
31
Basic Information
- Device Name
- HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
- K Number
- K071785
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITHS MEDICAL ASD, INC.
- Date Received
- July 2, 2007
- Decision Date
- August 2, 2007
- 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 |
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