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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K983232
Device Name PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
Applicant
Tz Medical, Inc.
15858 SW Upper Boones Ferry Rd.
Lake Oswego,  OR  97035
Applicant Contact BYRON G ZAHLER
Correspondent
Tz Medical, Inc.
15858 SW Upper Boones Ferry Rd.
Lake Oswego,  OR  97035
Correspondent Contact BYRON G ZAHLER
Regulation Number870.5550
Classification Product Code
DRO  
Date Received09/14/1998
Decision Date 09/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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