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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 5 of 5 Results
ProductCode: DYB Applicant: ONSET MEDICAL CORPORATION Decision Date To: 01/19/2021
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solopath re-collapsible access system ONSET MEDICAL CORPORATION K152498 01/05/2016
solopath re-collapsible access system ONSET MEDICAL CORPORATION K121404 05/03/2013
the solopath balloon expandable transfemoral introducer ONSET MEDICAL CORPORATION K100819 08/02/2010
solopath balloon expandable transfemoral introducer ONSET MEDICAL CORPORATION K092014 10/08/2009
balloon expandable transseptal indroducer, models beti-1840 and beti-1870 ONSET MEDICAL CORPORATION K062852 02/23/2007
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