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FDA 510(k) Applications Submitted by BIPORE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K961980
05/20/1996
BIPORE BALLOON DILATATION CATHETER
BIPORE, INC.
K973563
09/19/1997
BIPORE BALLOON DILATATION CATHETER
BIPORE, INC.
K983650
10/16/1998
BIPORE BALLOON DILATATION CATHETER
BIPORE, INC.
K964814
11/29/1996
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
BIPORE, INC.
K041293
05/14/2004
BIOPORE BALLOON DILATION CATHETER
BIPORE, INC.
K051513
06/02/2005
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
BIPORE, INC.
K073318
11/26/2007
BIPORE BALLOON DILATION CATHETER
BIPORE, INC.
K073434
12/06/2007
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
BIPORE, INC.
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