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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 K152201
Device Name MedActive Oral Gel and Spray
Applicant
Medactive Oral Pharmaceuticals, LLC
1900 Gunn Highway
Odessa,  FL  33556
Applicant Contact Brian Walker
Correspondent
Medactive Oral Pharmaceuticals, LLC
1900 Gunn Highway
Odessa,  FL  33556
Correspondent Contact Brian Walker
Classification Product Code
LFD  
Date Received08/06/2015
Decision Date 12/30/2015
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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