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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 K152876
Device Name LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
Applicant
Tni Manufacturing, Inc.
4635 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact DANIEL SABLYAK
Correspondent
Inneuroco
4635 NW 103rd Avenu
Sunrise,  FL  33351
Correspondent Contact MARIANNE GRUNWALDT
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/30/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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