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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 K900799
Device Name COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS
Applicant
Comfort Acrylics Co.
2103 NE 272nd Ave.
Camas,  WA  98607
Applicant Contact MOORE, DDS
Correspondent
Comfort Acrylics Co.
2103 NE 272nd Ave.
Camas,  WA  98607
Correspondent Contact MOORE, DDS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/20/1990
Decision Date 05/15/1990
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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