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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 K033130
Device Name PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
Applicant
Osypka Medical, Inc.
7855 Ivanhoe Ave., Suite 226
La Jolla,  CA  92037
Applicant Contact MARKUS J OSYPKA
Correspondent
Osypka Medical, Inc.
7855 Ivanhoe Ave., Suite 226
La Jolla,  CA  92037
Correspondent Contact MARKUS J OSYPKA
Regulation Number870.3600
Classification Product Code
DTE  
Date Received09/30/2003
Decision Date 10/31/2003
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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