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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biofeedback
510(k) Number K953257
Device Name ORALSENSOR
Applicant
CYCURA CORP.
P.O. BOX 364
ROCKLIN,  CA  95677
Applicant Contact KENT ANDERSON
Correspondent
CYCURA CORP.
P.O. BOX 364
ROCKLIN,  CA  95677
Correspondent Contact KENT ANDERSON
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/12/1995
Decision Date 02/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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