KNUMBER|APPLICANT|CONTACT|STREET1|STREET2|CITY|STATE|ZIP|DEVICENAME|DATERECEIVED|DECISIONDATE|DECISION|REVIEWADVISECOMM|PRODUCTCODE|STATEORSUMM|CLASSADVISECOMM|SSPINDICATOR|TYPE|THIRDPARTY|EXPEDITEDREVIEW|Country_Code|Postal_Code
K122556|LEICA BIOSYSTEMS NEWCASTLE LTD|BARBARA-ANN  CONWAY-MAYERS|5205 ROUTE 12||RICHMOND|IL|60071 |VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)|08/29/2012|05/19/2014|CS|PA|MYA|Summary|HE||Traditional|N|N|US|
K122656|SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD|LING  ZHU|12390 EAST END AVE.||CHINO|CA|91710 |POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR|08/31/2012|05/06/2014|SE|HO|LYZ|Summary|HO||Traditional|N|N|US|
K122817|ARGENTUM MEDICAL, LLC.|WALT  BRITTLE|810 LANDMARK DRIVE|SUITE 126|GLEN BURNIE|MD|21061 |SILVERLON ISLAND WOUND DRESSING|09/14/2012|05/01/2014|SE|SU|FRO|Summary|||Traditional|N|N|US|
K123099|AVAZZIA, INC.|TAMMY  LAHUTSKY|13140 Coit Rd Ste 515||DALLAS|TX|75240 |ALPHA-STIM MODEL ALPHA-STIM 100; BODY-STIM, BEST-RSI, BIOMODULATOR, MODEL BEST-PRO1; BEST-AV1; INTERX5000 MODEL INTERX50|03/07/2013|05/23/2014|SE|NE|GZJ|Summary|NE||Traditional|N|N|US|
K123126|SHANGHAI MOTEX HEALTHCARE CO., LTD.|JEN  KE-MIN|NO. 369, JIASONG ZHONG ROAD|HUAXIN, QINGPU|SHANGHAI|| |MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)|03/12/2013|06/04/2014|SE|HO|KGO|Summary|SU||Traditional|N|N|CH|201708
K123149|MAQUET CRITICAL CARE AB|WHITNEY  TORNING|45 BARBOUR POND DRIVE||WAYNE|NJ|07470 |SERVO-I VENTILATOR SYSTEM|11/05/2012|06/20/2014|SE|AN|CBK|Summary|AN||Abbreviated|N|N|US|
K123795|OTTO BOCK AUSTRIA|REINHARD  WOLKERSTORFER|KAISERSTRASSE 39||VIENNA|| |AXON-BUS PROSTHETIC SYSTEM|02/15/2013|06/03/2014|SE|PM|GXY|Summary|NE||Traditional|N|N|AU|A-1070
K123876|ODONTIT SA|BLIX  WINSTON|2600 MULLINIX MILL ROAD||MT AIRY|MD|21771 |SYNERGY|12/31/2012|05/22/2014|SE|DE|NPM|Summary|DE||Traditional|N|N|US|
K123940|DEMETECH CORP.|JOHN  O'BRIEN|445 APOLLO BEACH BLVD||APOLLO BEACH|FL|33572 |DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE|12/20/2012|05/30/2014|SE|SU|GAM|Summary|SU||Traditional|N|N|US|