510(k) Premarket Notification

• 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 Number: 880.5860
• Classification Product Code: MEG
• Subsequent Product Code: FMI
• Date Received: 07/16/2021
• 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