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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, pacemaker, temporary
510(k) Number K072770
Device Name TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
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 Number870.3680
Classification Product Code
LDF  
Date Received09/28/2007
Decision Date 01/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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