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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K854995
Device Name DENCLENZ
Applicant
Creighton Products Corp.
605 Third Ave.
New York,  NY  10158
Applicant Contact KARL MOHRMANN
Correspondent
Creighton Products Corp.
605 Third Ave.
New York,  NY  10158
Correspondent Contact KARL MOHRMANN
Regulation Number872.3520
Classification Product Code
EFT  
Date Received12/12/1985
Decision Date 05/12/1986
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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