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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K220603
Device Name Disposable Medical Safety Hypodermic Needle
Applicant
Hantech Medical Device Co., Ltd.
No 288, Sanheng Rd. Changhe Industridal Park, Cixi
Ningbo,  CN 315326
Applicant Contact Arnold YANG
Correspondent
Hantech Medical Device Co., Ltd.
No 288, Sanheng Rd. Changhe Industridal Park, Cixi
Ningbo,  CN 315326
Correspondent Contact Arnold YANG
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/02/2022
Decision Date 08/23/2022
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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