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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 K850650
Device Name DENTAL ACRYLIC POLYMERS
Applicant
Cole Polymers , Ltd.
686 Mitcham Rd.
Croydon Surrey,  GB CR9 3BG
Applicant Contact WOOD
Correspondent
Cole Polymers , Ltd.
686 Mitcham Rd.
Croydon Surrey,  GB CR9 3BG
Correspondent Contact WOOD
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/19/1985
Decision Date 05/22/1985
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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