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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K172297
Device Name NovaCross Microcatheter
Applicant
Nitiloop , Ltd.
4 Ha'Omanut St.
Netanya,  IL 4250438
Applicant Contact Chanan Schneider
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Ln.
Gardnerville,  NV  89460
Correspondent Contact Michael Daniel
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/31/2017
Decision Date 10/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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