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510(k) K231205

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray by Gurunanda, LLC — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2023
Date Received
April 27, 2023
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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