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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Dead Space Piston Syringe
510(k) Number K250138
Device Name Small Volume 0.2mL Syringe
Applicant
Prosum Medical Limited
Unit 14 Trade City Business Park, Cowley Mill Rd.
Uxbridge,  GB UB8 2DB
Applicant Contact Yanshen Sun
Correspondent
Kymanox
430 Davis Dr.
Suite #300
Morrisville,  NC  27560
Correspondent Contact Scott Zawko
Regulation Number880.5860
Classification Product Code
QNQ  
Date Received01/17/2025
Decision Date 04/02/2025
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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