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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 K173709
Device Name Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Applicant
Inneuroco, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact Marc Litzenberg
Correspondent
Inneuroco, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/04/2017
Decision Date 01/26/2018
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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