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FDA 510(k) Applications Submitted by DAVID LEHR
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160219
01/29/2016
Hilal Embolization MicroCoils
Cook Incorporated
K130766
03/20/2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
COOK, INC.
K191163
05/01/2019
Lumax Guiding Catheter
Cook Incorporated
K171820
06/19/2017
Transjugular Liver Access Sets
Cook Incorporated
K171853
06/21/2017
Liver Access and Biopsy Sets
Cook Incorporated
K151676
06/22/2015
Retracta Detachable Embolization Coil
COOK INCORPORATED
K132592
08/19/2013
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
COOK, INC.
K183036
11/01/2018
Dilator Sets
Cook Incorporated
K123707
12/03/2012
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
COOK, INC.
K153778
12/31/2015
Nester Embolization Coils, Tornado Embolization Coils
COOK INCORPORATED
K133114
09/30/2013
MICROPUNCTURE INTRODUCER SET
COOK INCORPORATED
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