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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 K232950
Device Name Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Applicant
Perfect Medical Industry (VN) Co., Ltd.
Block D/7I, No. 1B Road, Vinh Loc Industrial Zone
Binh Hung Hoa B Ward, Bin Tan District
Ho Chi Minh City,  VN 700000
Applicant Contact Nancy Phan
Correspondent
Emergo Global Consulting , LLC
2500 Bee Cave Road, Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Thomas Huang
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   MEG  
Date Received09/20/2023
Decision Date 06/12/2024
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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