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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 K890043
Device Name DENTCLEAN CONCENTRATED DENTURE CLEANSER
Applicant
K-P Co.
4857 Delhi Rd.
Cincinnati,  OH  45238
Applicant Contact PHILIP A PAOLELLO
Correspondent
K-P Co.
4857 Delhi Rd.
Cincinnati,  OH  45238
Correspondent Contact PHILIP A PAOLELLO
Regulation Number872.3520
Classification Product Code
EFT  
Date Received01/05/1989
Decision Date 06/07/1989
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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