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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K200932
Device Name Blood Collection Needles
Applicant
Vacutest Kima Srl
Via Dell'Industria 12
Arzegrande,  IT 35020
Applicant Contact Monica Vianello
Correspondent
Vacutest Kima Srl
Via Dell'Industria 12
Arzegrande,  IT 35020
Correspondent Contact Elisa Buggio
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/07/2020
Decision Date 12/14/2021
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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