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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K881422
Device Name COE PAK AUTO MIX, REGULAR OR HARD SET
Applicant
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Applicant Contact BRAHMA D SHARMA,PHD
Correspondent
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Correspondent Contact BRAHMA D SHARMA,PHD
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/05/1988
Decision Date 10/31/1988
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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