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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 K033020
Device Name IMPAK ACRYLIC REPAIR RESIN LIQUID
Applicant
Cmp Industries, LLC
413 N. Pearl St.
Albany,  NY  12207
Applicant Contact WILLIAM REGAN
Correspondent
Cmp Industries, LLC
413 N. Pearl St.
Albany,  NY  12207
Correspondent Contact WILLIAM REGAN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/26/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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