FDA 510(k) Applications for Medical Device Product Code "OKO"

FDA 510(k) Number Applicant Device Name Decision Date
K193185 BenQ Materials Corporation Anscare SIMO Negative Pressure Wound Therapy (NPWT) System 05/04/2020
K212971 Guard Medical Inc NPseal 02/10/2022
K200305 Guard Medical Inc. NPseal 05/26/2020
K211130 Guard Medical Inc. NPseal 05/14/2021
K111006 SPIRACUR, INC. CI-SNAP WOUND CARE SYSTEM 07/21/2011
K133137 SPIRACUR, INC. CISNAP CLOSED INCISION SYSTEM 02/25/2014
K111393 SPIRACUR, INC. SNAP (R) WOUND CARE SYSTEM 07/28/2011
DEN080011 SPIRACUR, INC. SNAP WOUND CARE DEVICE 08/07/2009
K142272 SPIRACUR, INC. SNaP Wound Care System 11/25/2014
K151710 SPIRACUR, INC. SNaP Wound Care System 11/19/2015
K112341 SPIRACUR, INC. SNAP WOUND CARE SYSTEM 08/29/2011
K113032 SPIRACUR, INC. SNAP WOUND CARE SYSTEM 12/01/2011
K132080 SPIRACUR, INC. SNAP WOUND CARE SYSTEM 03/12/2014


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