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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 K071617
Device Name ORAL NEUTRALIZER
Applicant
ORAL BIOTECH
812 WATER ST. NE
ALBANY,  OR  97321
Applicant Contact ROBERT BOWERS
Correspondent
ORAL BIOTECH
812 WATER ST. NE
ALBANY,  OR  97321
Correspondent Contact ROBERT BOWERS
Classification Product Code
LFD  
Date Received06/13/2007
Decision Date 10/19/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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