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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 K110116
Device Name XEROS DRY MOUTH PUMP
Applicant
LORIN TECHNOLOGIES CORPORATION
436 WOODLAND DR
swansboro,  NC  28584
Applicant Contact al toman
Correspondent
LORIN TECHNOLOGIES CORPORATION
436 WOODLAND DR
swansboro,  NC  28584
Correspondent Contact al toman
Classification Product Code
LFD  
Date Received01/14/2011
Decision Date 04/08/2011
Decision substantially equivalent (SESE)
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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