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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 K020896
Device Name OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
Applicant
Osypka Medical, Inc.
7463 Draper Ave.
La Jolla,  CA  92037
Applicant Contact MARKUS J OSYPKA
Correspondent
Osypka Medical, Inc.
7463 Draper Ave.
La Jolla,  CA  92037
Correspondent Contact MARKUS J OSYPKA
Regulation Number870.3600
Classification Product Code
DTE  
Date Received03/19/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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