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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K222905
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)
Applicant
Ningbo Maxcon Medical Technology Co., Ltd.
#228 Dongxin Rd., Dongqiao Town
Ningbo,  CN 315000
Applicant Contact Puhai Ma
Correspondent
Shenglin (Hangzhou) Consultants, Inc.
Rm. 2506, Unit 1#, Bldg. 5#, Ronghui Business Center,
Economic Development Zone
Hangzhou,  CN 310018
Correspondent Contact Henry Zhang
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/23/2022
Decision Date 06/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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