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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 K253222
Device Name Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Applicant
Zhejiang Gongdong Medical Technology Co., Ltd.
# 10 & 39, Beiyuan Ave.
# 8 Jingxian Rd. Huangyan
Taizhou,  CN 318020
Applicant Contact Jingxiang Zhang
Correspondent
Zhejiang Gongdong Medical Technology Co., Ltd.
No 10 & 39, Beiyuan Ave.
# 88 Jingxian Rd. Huangyan
Taizhou,  CN 318020
Correspondent Contact Jingxiang Zhang
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/29/2025
Decision Date 12/22/2025
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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