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FDA 510(k) Applications Submitted by Neil Kelly
FDA 510(k) Number
Submission Date
Device Name
Applicant
K120567
02/27/2012
GYRUS AMCI PK BUTTON ELECTRODE
GYRUS ACMI, INC.
K071066
04/16/2007
SPYCATCH STONE RETRIEVAL BASKET
BOSTON SCIENTIFIC CORP.
K132181
07/15/2013
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K132383
07/31/2013
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
GYRUS ACMI, INC.
K142154
08/06/2014
PK NEEDLE
GYRUS ACMI, INC.
K152219
08/07/2015
PK AIM
GYRUS ACMI INC
K142289
08/18/2014
PK Spatula
Gyrus ACMI Inc.
K142350
08/22/2014
PK J-HOOK
GYRUS ACMI INC.
K122605
08/27/2012
PKS BILL
GYRUS ACMI, INC.
K123319
10/26/2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
K073266
11/20/2007
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
BOSTON SCIENTIFIC CORP.
K163623
12/22/2016
Quantra
HOLOGIC, INC.
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