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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, impression
510(k) Number K903292
Device Name ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS
Applicant
COE LABORATORIES, INC.
3737 W. 127TH ST.
alsip,  IL  60658
Applicant Contact richard s demke
Correspondent
COE LABORATORIES, INC.
3737 W. 127TH ST.
alsip,  IL  60658
Correspondent Contact richard s demke
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/24/1990
Decision Date 10/19/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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