FDA 510(k) Applications Submitted by SAM R NIEDBALA

FDA 510(k) Number Submission Date Device Name Applicant
K180211 01/25/2018 Freezpoint Bovie Medical Corp.
K190407 02/21/2019 CryoLab CryoConcepts LP
K211099 04/13/2021 FreezeÆn Clear Skin Clinic Warts & Tags CryoConcepts LP
K183601 12/26/2018 CryoTouch CryoConcepts LP
K982061 06/04/1998 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) ORASURE TECHNOLOGIES, INC.
K972481 07/02/1997 AUTO-LYTE COTININE EIA ORASURE TECHNOLOGIES, INC.
K974234 11/12/1997 MICRO-PLATE COTININE EIA ORASURE TECHNOLOGIES, INC.


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