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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K030547
Device Name MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
Applicant
Guardian Angel Products, Inc.
2771 Philmont Ave.
Huntingdon Valley,  PA  19006
Applicant Contact ERNEST H PESCATORE
Correspondent
Guardian Angel Products, Inc.
2771 Philmont Ave.
Huntingdon Valley,  PA  19006
Correspondent Contact ERNEST H PESCATORE
Regulation Number870.5325
Classification Product Code
DRL  
Date Received02/20/2003
Decision Date 07/11/2003
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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