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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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panel: Gastroenterology/Urology Decision Date To: 05/17/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 K010312 08/01/2001
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
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