FDA 510(k) Application Details - K073152

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K073152
Device Name Recorder, Magnetic Tape, Medical
Applicant SHENZHEN CREATIVE INDUSTRY CO., LTD
2/F, BLOCK 3 NANYOU TIAN'
AN INDUSTRY TOWN
SHENZHEN,GD 518054 CN
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 11/08/2007
Decision Date 01/10/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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