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FDA 510(k), K112219, TAPAS CATHETER
FDA 510(k), K112219, TAPAS CATHETER
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510(K) Number: K112219
Device Name: TAPAS CATHETER
Manufacturer: THOMAS SCHROEDER
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 08/02/2011
Decision Date: 11/18/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TAPAS CATHETER
Manufacturer: THOMAS SCHROEDER
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 08/02/2011
Decision Date: 11/18/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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