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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 K251089
Device Name EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
Applicant
Exelint International, Co.
2500 Santa Fe Ave.
Redondo Beach,  CA  90278
Applicant Contact Stefanie Ng
Correspondent
Exelint International, Co.
2500 Santa Fe Ave.
Redondo Beach,  CA  90278
Correspondent Contact Stefanie Ng
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   MEG  
Date Received04/10/2025
Decision Date 12/12/2025
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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