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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K924974
Device Name THE TMJ APPLIANCE
Applicant
Myofunctional Research Corp. Pty. , Ltd.
P.O. Box 14
Helensvale, Queensland,  AU 4212
Applicant Contact CHRIS FARRELL
Correspondent
Myofunctional Research Corp. Pty. , Ltd.
P.O. Box 14
Helensvale, Queensland,  AU 4212
Correspondent Contact CHRIS FARRELL
Regulation Number872.5525
Classification Product Code
KMY  
Date Received09/30/1992
Decision Date 06/23/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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