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FDA 510(k), K142245, EpiAccess System
FDA 510(k), K142245, EpiAccess System
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510(K) Number: K142245
Device Name: EpiAccess System
Manufacturer: Pamela Bunes
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: KXA
Date Received: 08/13/2014
Decision Date: 10/29/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: EpiAccess System
Manufacturer: Pamela Bunes
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: KXA
Date Received: 08/13/2014
Decision Date: 10/29/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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