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FDA 510(k), K023914, COAXIA FLOCONTROL CATHETER
FDA 510(k), K023914, COAXIA FLOCONTROL CATHETER
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510(K) Number: K023914
Device Name: COAXIA FLOCONTROL CATHETER
Manufacturer: GREGORY W SACHS
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 11/25/2002
Decision Date: 02/21/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: COAXIA FLOCONTROL CATHETER
Manufacturer: GREGORY W SACHS
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 11/25/2002
Decision Date: 02/21/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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