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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K231205
Device Name GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
Applicant
Gurunanda, LLC
6645 Caballero Blvd.
Buena Park,  CA  90620
Applicant Contact Puneet Nanda
Correspondent
Gurunanda, LLC
6645 Caballero Blvd.
Buena Park,  CA  90620
Correspondent Contact Chetan Patel
Classification Product Code
LFD  
Date Received04/27/2023
Decision Date 08/22/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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