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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 K242434
Device Name Insulin Syringes
Applicant
Chirana T. Injecta
Nám. Dr. Schweitzera 194
Stará Turá,  SK 91601
Applicant Contact Rastislav Broska
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received08/16/2024
Decision Date 12/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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