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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 K003918
Device Name OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
Applicant
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.3680
Classification Product Code
DTB  
Date Received12/19/2000
Decision Date 05/22/2001
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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