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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K201009
Device Name CHIRAVAC Blood Collection Needles
Applicant
CHIRANA T. Injecta
Nàm. Dr. Schweitzera 194
Starà Turà,  SK 916 01
Applicant Contact Zdenka Klbeckova
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received04/17/2020
Decision Date 07/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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