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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
Recalls CDRH Recalls
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