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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 K022939
Device Name OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
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 Received09/04/2002
Decision Date 10/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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