FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
K Number: K222905
·
Decision Jun 1, 2023
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
108
Applicant Total
4
Review Days
251
Basic Information
- Device Name
- Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
- K Number
- K222905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ningbo Maxcon Medical Technology Co., Ltd.
- Date Received
- September 23, 2022
- Decision Date
- June 1, 2023
- Product Code
- MMK
- 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 |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
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