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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: LZG Applicant: INSULET CORPORATION Decision Date To: 01/28/2023
 
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ixl-ii diabetes management system INSULET CORPORATION K042792 01/03/2005
freestyle glucose meter incorporated into the omnipod insulin management systems INSULET CORPORATION K111669 12/15/2011
omnipod insulin managment system INSULET CORPORATION K122953 12/07/2012
omnipod insulin management system INSULET CORPORATION K131294 08/29/2013
omnipod insulin management system INSULET CORPORATION K140439 11/13/2014
omnipod insulin management system INSULET CORPORATION K160252 04/27/2016
omnipod insulin management system INSULET CORPORATION K162296 04/18/2017
omnipod dash insulin management system Insulet Corporation K180045 06/01/2018
omnipod insulin management system, omnipod dash insulin management system Insulet Corporation K182630 01/08/2019
omnipod insulin management system, omnipod dash insulin management system Insulet Corporation K192659 10/21/2019
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