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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K130633
Device Name INTRODUCER SETS, MODEL ADELANTE RADIAL
Applicant
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/11/2013
Decision Date 02/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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