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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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crescent spinal system MEDTRONIC SOFAMOR DANEK, INC. k133216 11/22/2013
aze phoenix software AZE, LTD. k133521 04/11/2014
n8tive acl anatomic reconstruction system, n8tive acl femoral implant, n8tive acl tibial implant, various class i ancill ARTHROCARE CORPORATION k133606 04/01/2014
mars monitor itc us, mars treatment kit type 1116/1 - x-mars us, prismaflex control unit GAMBRO RENAL PRODUCTS, INC. k133807 03/26/2014
8mm trocar kit INTUITIVE SURGICAL k133845 02/19/2014
filmarray rp panel IDAHO TECHNOLOGY, INC. k120267 05/15/2012
powder free vinyl patient examination gloves, clear (non-colored) HONGXIN PLASTIC PRODUCTS CO., LTD k120358 03/06/2012
brain port NICO CORPORATION k120691 06/05/2012
heartcheck ecg pen with gems home CARDIO COMM SOLUTIONS, INC. k121009 05/17/2012
fuse cage ADVANCED MEDICAL TECHNOLOGIES AG k121288 06/29/2012

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