FDA 510(k), K130872, CARDIOCEL

FDA 510(k), K130872, CARDIOCEL

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510(K) Number: K130872
Device Name: CARDIOCEL
Manufacturer: CHRISTOPHER SLOAN
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: DXZ
Classification Product Code: KXA
Date Received: 03/29/2013
Decision Date: 01/30/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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