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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 K981693
Device Name SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
Applicant
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Applicant Contact DENISE E SPELLMAN
Correspondent
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Correspondent Contact DENISE E SPELLMAN
Classification Product Code
LFD  
Date Received05/13/1998
Decision Date 08/06/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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