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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 12 Results
ProductCode: DQX Applicant: LAKE REGION MEDICAL Decision Date To: 05/10/2024
 
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pre-formed blue Lake Region Medical K221575 10/07/2022
pre-formed extra support guidewire Lake Region Medical K211741 11/22/2021
hi-torque vektor, .014, 195cm, str, hi-torque vektor, .014, 195cm, j, hi-torque vektor, .014, 300cm, str, hi-torque vektor, .014, 300cm, j Brivant Limited (Lake Region Medical) K182457 04/18/2019
enroute 0.014 guidewire LAKE REGION MEDICAL K160643 10/18/2016
pre-formed guidewire Lake Region Medical K151244 06/11/2015
hi torque connect guidewire, hi torque connect flex guidewire, hi torque connect 250t guidewire LAKE REGION MEDICAL K140536 12/17/2014
predicate iii guidewire LAKE REGION MEDICAL K142393 11/25/2014
hydrophilic coated guidewire LAKE REGION MEDICAL K133155 04/07/2014
mandrel guidewire LAKE REGION MEDICAL K140485 03/27/2014
pre-formed guidewires LAKE REGION MEDICAL, INC. K130798 08/23/2013
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