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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K971818
Device Name SNOREX
Applicant
Snorex (Nz) , Ltd.
8210 Carrleigh Pkwy.
Springfield,  VA  22152
Applicant Contact VERNON PRIBBLE
Correspondent
Snorex (Nz) , Ltd.
8210 Carrleigh Pkwy.
Springfield,  VA  22152
Correspondent Contact VERNON PRIBBLE
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received05/16/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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