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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 K123916
Device Name PSA SERIES
Applicant
OSYPKA MEDICAL, INC.
7855 IVANHOE AVE., SUITE 226
LA JOLLA,  CA  92037
Applicant Contact MARKUS OSYPKA
Correspondent
OSYPKA MEDICAL, INC.
7855 IVANHOE AVE., SUITE 226
LA JOLLA,  CA  92037
Correspondent Contact MARKUS OSYPKA
Regulation Number870.3600
Classification Product Code
DTE  
Subsequent Product Code
DTA  
Date Received12/19/2012
Decision Date 04/09/2013
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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