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FDA 510(k) Application Details - K020825

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K020825
Device Name Recorder, Magnetic Tape, Medical
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
6779 MESA RIDGE RD.
SUITE 200
SAN DIEGO, CA US
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Contact ALDEN KAY
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 03/14/2002
Decision Date 04/05/2002
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review N



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