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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 K160805
Device Name NIO-P
Applicant
Waismed, Ltd.
10 Amal St. Afek Industrial Park
Rosh Ha'Ayin,  IL 4809234
Applicant Contact Einat Swisa
Correspondent
Hogan Lovells US LLP
Columbia Sq. 555 Thirteenth St.
Washington,  DC  20004
Correspondent Contact Jonathan S. Kahan
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/23/2016
Decision Date 06/23/2016
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
Recalls CDRH Recalls
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