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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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.014 monorail and otw pta balloon dilatation catheters Boston Scientific Corporation k111295 05/31/2011
0.9% sodium chloride injection, usp - 2.5 ml in 3 ml syringe, 0.9% sodium chloride injection, usp-3ml in 10 ml syringe, 0.9% sodium chloride injection, usp - 5 ml in 10 ml syringe, 0.9% sodium chloride injection, usp - 10 ml in 10 ml syringe Excelsior Medical Corporation k142620 12/12/2014
2.5mm turbo elite 035, 2.3mm turbo elite 035 SPECTRANETICS CORP. k123632 01/25/2013
5.0mm spinal screws ORTHOTEC, L.L.C. k994288 04/10/2000
7250 (megas) BIOSOUND ESAOTE, INC. k994369 02/24/2000
8mm trocar kit INTUITIVE SURGICAL k133845 02/19/2014
aart calf implant AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. k022511 08/26/2002
ab command dual channel fitness belt LETO ENTERPRISES INCORPORATION k122414 12/21/2012
abl 77 ph, blood gas and electrolyte analysis system SENDX MEDICAL, INC. k994346 02/01/2000
access ck-mb on the access immunoassay analyzer, models 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. k994439 01/14/2000

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