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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name permanent pacemaker electrode
510(k) Number K040569
Device Name PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
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
DTB  
Date Received03/04/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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