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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K130843
Device Name SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.1390
Classification Product Code
DRC  
Date Received03/27/2013
Decision Date 01/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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