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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 K852981
Device Name PREFORMED TOOTH ARCH
Applicant
Swipes Dental Laboratory
P.O. Box 2061
Harrisburg,  PA  17105
Applicant Contact EDWARD L DAHOWSKI
Correspondent
Swipes Dental Laboratory
P.O. Box 2061
Harrisburg,  PA  17105
Correspondent Contact EDWARD L DAHOWSKI
Regulation Number872.3590
Classification Product Code
ELM  
Date Received07/15/1985
Decision Date 08/16/1985
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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