FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
INSULIN PEN NEEDLE
K Number: K133058
·
Decision Feb 25, 2014
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
2
Review Days
151
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Basic Information
- Device Name
- INSULIN PEN NEEDLE
- K Number
- K133058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wenzhou Wuzhou Import & Export Co., Ltd.
- Date Received
- September 27, 2013
- Decision Date
- February 25, 2014
- 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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Other Clearances by Wenzhou Wuzhou Import & Export Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K110421 | DISPOSABLE INSULIN SYRINGE | Apr 26, 2011 | Substantially Equivalent |