FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

K Number: K222906 · Decision Jun 16, 2023
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
4
Review Days
266

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Basic Information

Device Name
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K Number
K222906
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 16, 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
MMK Container, Sharps

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Other Clearances by Ningbo Maxcon Medical Technology Co., Ltd.

K Number Device Name
K222905 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)
K180984 Maxcon Sharps Container
K180983 Maxcon Two Gallon Chemotherapy Container