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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K955701
Device Name NIGHTGUARD DIAGNOSTIC APPLIANCE
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
Classification Product Code
MQC  
Date Received12/15/1995
Decision Date 03/08/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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