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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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Date
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xvac SORIN GROUP ITALIA S.R.L. k110782 04/07/2011
jetpack 2.0 PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. k111024 04/21/2011
flash-c ptca balloon dilation catheter - 5mm x 19mm x 135cm / 6mm x 19mm x 135cm OSTIAL CORPORATION k111284 08/17/2011
elecsys precicontrol varia 3 Roche Diagnostics k111506 07/08/2011
hoffmann 3 modular external fixation system STRYKER CORP. k111786 01/26/2012
aerochamber plus flow-vu anti-static valved holding chamber (vhc) TRUDELL MEDICAL INTL. k112010 07/11/2012
sarn centrifugal pump TERUMO CARDIOVASCULAR SYSTEMS k112229 12/09/2011
biomerix composite surgical mesh BIOMERIX CORPORATION k112499 12/23/2011
bd recykleen sharps collectors Becton, Dickinson and Company k112774 03/28/2012
pain-aid PDI WORKS, LLC. k113037 03/01/2012

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