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U.S. Department of Health and Human Services

510(K) Premarket Notification
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disposable powder free vinyl synthetic exam gloves, with aloe vera, green color FULL SYNERGY MEDICAL PRODUCTS INC k113749 03/15/2012
btl elite BTL INDUSTRIES, INC k120093 10/05/2012
capstone control spinal system MEDTRONIC SOFAMOR DANEK USA, INC. k120368 04/09/2012
k-laser ELTECH S.R.L k120604 05/25/2012
lsh (mangofilcon a) sphere soft (hydrophilic) contact lens, lsh (mangofilcon a) multifocal soft (hydrophilic) contact le THE LAGADO CORP. k120756 05/13/2013
orbit NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC k120880 04/19/2012
transcorp acif system TRANSCORP, INC. k121178 07/05/2013
osom ifob 25 test and patient collection kit osom ifob control kit osom ifob 50 test kit SEKISUI DIAGNOSTICS, LLC k121397 12/28/2012
wondfo cannabinoids urine test wondfo propoxyphene urine test Guangzhou Wondfo Biotech Co., Ltd. k121557 07/25/2012
perf-gen pulsatile perfusion solution WATERS MEDICAL SYSTEMS, LLC k121736 08/16/2013

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