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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 K150074
Device Name Elevate Moisturizing Spray
Applicant
Elevate Oral Care
346 Pike Rd.
Suite 5
West Palm Beach,  FL  33411
Applicant Contact STEVE PARDUE
Correspondent
Elevate Oral Care
346 Pike Rd.
Suite 5
West Palm Beach,  FL  33411
Correspondent Contact STEVE PARDUE
Classification Product Code
LFD  
Date Received01/14/2015
Decision Date 06/19/2015
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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