FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Pen Injector Assembly
K Number: K240961
·
Decision Aug 15, 2024
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
4
Review Days
129
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Basic Information
- Device Name
- Disposable Pen Injector Assembly
- K Number
- K240961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wuxi Nest Biotechnology Co., Ltd.
- Date Received
- April 8, 2024
- Decision Date
- August 15, 2024
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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