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FDA 510(k) Applications Submitted by Sam 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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