K-numberK020896
Device nameOSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
ApplicantOsypka Medical, Inc.
Product codeDTE
Device classClass II
Decision dateJun 14, 2002
DecisionSubstantially Equivalent
Regulation870.3600
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