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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K852741
Device Name DURA CONDITIONER
Applicant
Reliance Dental Mfg. Co.
5805 W. 117th Pl.
Worth,  IL  60482
Applicant Contact ROBERT J FAXEL
Correspondent
Reliance Dental Mfg. Co.
5805 W. 117th Pl.
Worth,  IL  60482
Correspondent Contact ROBERT J FAXEL
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/27/1985
Decision Date 09/23/1985
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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