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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 K180984
Device Name Maxcon Sharps Container
Applicant
Ningbo Maxcon Medical Technology Co., Ltd.
#30 Dongbei Rd./#228 Dong Xin Rd., Dong Qiao Town
Ningbo,  CN 315157
Applicant Contact Yang Song
Correspondent
Ningbo Maxcon Medical Technology Co., Ltd.
#30 Dongbei Rd./#228 Dong Xin Rd., Dong Qiao Town
Ningbo,  CN 315157
Correspondent Contact Yang Song
Regulation Number880.5570
Classification Product Code
MMK  
Date Received04/13/2018
Decision Date 01/03/2019
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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