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U.S. Department of Health and Human Services

510(K) Premarket Notification

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short surelock all-suture anchor, 1.4mm with (1) size 0 uhmwpe suture with needles, short surelock all-suture anchor, 1.4mm with (1) size 2-0 uhmwpe suture with needles CAYENNE MEDICAL, INC k143473 03/25/2015
t-8000 therozone unit THEROZONE USA, INC. k141504 02/24/2015
non-sterile, powder free scented blue nitrile examination gloves - grape, apple, peppermint, vanilla YTY INDUSTRY (MANJUNG) SDN. BHD. k143055 02/12/2015
immunalysis amphetamine urine enzyme immunoassay, immunalysis amphetamine urine calibrator, immunalysis amphetamine urine control set Immunalysis Corporation k143500 02/06/2015
powder free nitrile examination glove, blue (colored). Careplus (M) SDN BHD k142862 01/16/2015
super sheath TOGO MEDIKIT CO., LTD. k141070 01/15/2015
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
amedica valeo ii interbody fusion device Amedica Corp k142347 11/18/2014
acrobat calibrated tip wire guide Wilson-Cook Medical, Inc k142950 11/05/2014
medline neuro sponge MEDLINE INDUSTRIES, INC. k140369 09/26/2014

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