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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 K152406
Device Name SalivaMAX
Applicant
Forward Science, LLC
3944 Bluebonnet Dr.
Stafford,  TX  77477
Applicant Contact Brian Pikkula
Correspondent
Forward Science, LLC
3944 Bluebonnet Dr.
Stafford,  TX  77477
Correspondent Contact Brian Pikkula
Classification Product Code
LFD  
Date Received08/25/2015
Decision Date 12/23/2015
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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