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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 K990142
Device Name HT, MODEL HT PB
Applicant
Sulzer Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Sulzer Oscor, Inc.
3816 Desoto Blvd.
Palm Harbor,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.3680
Classification Product Code
DTB  
Date Received01/19/1999
Decision Date 07/30/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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