FDA 510(k) Applications Submitted by Bolder Surgical, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K202114 07/30/2020 CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 Bolder Surgical, LLC
K203183 10/27/2020 CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) Bolder Surgical, LLC
K203640 12/14/2020 CoolSeal Reveal Bolder Surgical, LLC


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