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510(k) K250390

CloSYS® Dry Mouth Sensitive Mouth Rinse by Rowpar Pharmaceuticals, Inc. — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2025
Date Received
February 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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