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510(k) K170270

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline by Ls Scientific Inc. D.B.A. Kse Scientific — Product Code FRO

K170270 is an FDA 510(k) premarket notification submitted by Ls Scientific Inc. D.B.A. Kse Scientific for the device "Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 23, 2017
Date Received
Jan 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources