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FDA 510(k), K141453, ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
FDA 510(k), K141453, ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
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$149.00 USD
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$149.00 USD
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510(K) Number: K141453
Device Name: ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
Manufacturer: JEFFREY ROBERTS
Device Classification Name: Catheter, Intravascular, Diagnostic
Regulation Number: DQO
Classification Product Code: 06/02/2014
Date Received: 09/19/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
Manufacturer: JEFFREY ROBERTS
Device Classification Name: Catheter, Intravascular, Diagnostic
Regulation Number: DQO
Classification Product Code: 06/02/2014
Date Received: 09/19/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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