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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K190002
Device Name Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
Applicant
Shanghai Kohope Medical Devices Co., Ltd.
Rm. 1001, #2 Bldg., Ln. 2888
South Qilian Mountains Rd.
Shanghai,  CN 200331
Applicant Contact Yibing Wang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong Hong
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received01/02/2019
Decision Date 09/12/2019
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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