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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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