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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 K190538
Device Name NIO-I
Applicant
Waismed, Ltd.
10 Amal St. Afeck Industrial Park
Rosh Haayin,  IL 4809234
Applicant Contact Maya Shuvi
Correspondent
Talmed , Ltd.
M.P Upper Galilee
Ramot-Naftali,  IL 1383000
Correspondent Contact Tali Hazan
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MHC  
Date Received03/04/2019
Decision Date 10/07/2019
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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