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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Pacemaker
510(k) Number K933278
Device Name INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
Applicant
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Applicant Contact TODD A FONSECA
Correspondent
Intermedics, Inc.
4000 Technology Dr.
Angleton,  TX  77515
Correspondent Contact TODD A FONSECA
Regulation Number870.3700
Classification Product Code
KRG  
Date Received06/29/1993
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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