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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K936058
Device Name OPTODENT/OPTOGNATH
Applicant
Spectrum Healthcare Group
P.O. Box 396
Fairburn,  GA  30213
Applicant Contact PHILLIP BONNER
Correspondent
Spectrum Healthcare Group
P.O. Box 396
Fairburn,  GA  30213
Correspondent Contact PHILLIP BONNER
Regulation Number872.3590
Classification Product Code
ELM  
Date Received12/20/1993
Decision Date 05/16/1994
Decision Substantially Equivalent (SESE)
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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