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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 K122084
Device Name INTRODUCER SET, MODEL ADELANTE-S SERIES
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
Correspodent Contact mila doskocil
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/16/2012
Decision Date 08/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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