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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 K111250
FOIA Releasable 510(k) K111250
Device Name DRY MOUTH MOUTHWASH
Applicant
Dr. Fresh, Inc.
Medical Devices
144 Research Dr.
Hampton,  VA  23666
Applicant Contact CAMILLE THORNTON
Correspondent
Dr. Fresh, Inc.
Medical Devices
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact CAMILLE THORNTON
Classification Product Code
LFD  
Date Received05/04/2011
Decision Date 04/27/2012
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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