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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K955882
Device Name MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Applicant Contact KATHLEEN SELOVER
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Correspondent Contact KATHLEEN SELOVER
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/28/1995
Decision Date 10/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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