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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 K180680
Device Name Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
Applicant
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Applicant Contact Michael Pellico
Correspondent
Laclede, Inc.
2103 E. University Dr.
Rancho Dominguez,  CA  90220
Correspondent Contact Rajvinder Atwal
Classification Product Code
LFD  
Date Received03/15/2018
Decision Date 10/11/2018
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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