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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 K910795
Device Name COMFOR-DENT DENTURE LINER
Applicant
Comfort Acrylics Co.
12716 NE 7th Pl.
Vancouver,  WA  98684
Applicant Contact SHERMAN L WATSON
Correspondent
Comfort Acrylics Co.
12716 NE 7th Pl.
Vancouver,  WA  98684
Correspondent Contact SHERMAN L WATSON
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/26/1991
Decision Date 07/11/1991
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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