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510(k) K201138

AMSure® Single Use Saline Topical Solution by Amsino Medical, Inc. — Product Code FRO

K201138 is an FDA 510(k) premarket notification submitted by Amsino Medical, Inc. for the device "AMSure® Single Use Saline Topical Solution". The FDA issued a decision of Substantially Equivalent on Apr 14, 2021. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 14, 2021
Date Received
Apr 28, 2020
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