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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 K142549
Device Name Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
Applicant
J.C.E.C. Company, Inc. (doing business as Fountain Health Ca
12 Frieda Lane
Kendall Park,  NJ  08824
Applicant Contact John Canvin
Correspondent
B&H Consulting Services, Inc.
50 Division Street, Suite 206
Somerville,  NJ  08876
Correspondent Contact Elizabeth N. Dupras
Classification Product Code
LFD  
Date Received09/10/2014
Decision Date 05/26/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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