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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K970497
Device Name PACE 101H
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 Number870.3600
Classification Product Code
DTE  
Date Received02/10/1997
Decision Date 06/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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