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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 K240508
Device Name Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
Applicant
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Applicant Contact Stephen Pellico
Correspondent
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Correspondent Contact Rajvinder Atwal
Classification Product Code
LFD  
Date Received02/21/2024
Decision Date 04/19/2024
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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