FDA 510(k) Applications Submitted by MOLNLYCKE HEALTH CARE, US LLC

FDA 510(k) Number Submission Date Device Name Applicant
K151872 07/09/2015 Avance Y-Connector S MOLNLYCKE HEALTH CARE, US LLC
K141719 06/25/2014 BIOGEL PL MICRO SURGICAL GLOVE MOLNLYCKE HEALTH CARE, US LLC
K190077 01/16/2019 Biogel« PI UltraTouch S Surgical Glove, Biogel« Pl Ultra Touch S Indicator Underglove Molnlycke Health Care, US LLC
K191869 07/12/2019 Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim Molnlycke Health Care, US LLC
K202090 07/28/2020 Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underg Molnlycke Health Care, US LLC
K160379 02/10/2016 Exufiber Ag+ MOLNLYCKE HEALTH CARE, US LLC
K161797 06/30/2016 Avance Tubing, Avance Y-Connector, Avance ViewPad MOLNLYCKE HEALTH CARE, US LLC
K161935 07/14/2016 Avance Foam Dressing Kit - XL MOLNLYCKE HEALTH CARE, US LLC
K161948 07/15/2016 Avance Gauze Dressing Kits MOLNLYCKE HEALTH CARE, US LLC
K152741 09/23/2015 Mepiseal Soft Silicone Sealant MOLNLYCKE HEALTH CARE, US LLC


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