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FDA 510(k) Applications Submitted by Leonard Stewart
FDA 510(k) Number
Submission Date
Device Name
Applicant
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
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