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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K031164
Device Name PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Applicant Contact MILA DOCKOCIL
Correspondent
Oscor, Inc.
4875 Palm Harbor Blvd.
Palm Harbor,  FL  34683
Correspondent Contact Ron Greco
Regulation Number870.3620
Classification Product Code
DTD  
Date Received04/14/2003
Decision Date 06/19/2003
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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