FDA 510(k) Application Details - K030547

Device Classification Name Tester, Defibrillator

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510(K) Number K030547
Device Name Tester, Defibrillator
Applicant GUARDIAN ANGEL PRODUCTS, INC.
2771 PHILMONT AVE.
HUNTINGDON VALLEY, PA 19006 US
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Contact ERNEST H PESCATORE
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Regulation Number 870.5325

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Classification Product Code DRL
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Date Received 02/20/2003
Decision Date 07/11/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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