FDA 510(k) Application Details - K181529

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K181529
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant Contego Medical, LLC
3921 Sunset Ridge Rd., Suite 102
Raliegh, NC 27607 US
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Contact Elizabeth Saylors
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 06/11/2018
Decision Date 12/06/2018
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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