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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 K831095
Device Name ROYALE II
Applicant
Factor, Ii, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Factor, Ii, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/04/1983
Decision Date 08/31/1983
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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