FDA 510(k) Application Details - K031442

Device Classification Name Wire, Guide, Catheter

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510(K) Number K031442
Device Name Wire, Guide, Catheter
Applicant MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE, FL 32608 US
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Contact KARL SWARTZ
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/06/2003
Decision Date 08/13/2003
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 N
Expedited Review



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