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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, antistick
510(k) Number K212226
Device Name DR Safety Syringe, Sterile Hypodermic needle for Single use
Applicant
Zhuhai DR Medical Instruments Co., Ltd
Floor 4, Factory Building A, No.288, East Airport Road,
Jinwan District
zhuhai,  CN
Applicant Contact xu jianhai
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received07/16/2021
Decision Date 09/29/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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