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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 K844572
Device Name PRE-KLENE ENAMEL CLEANER
Applicant
Medical Products Laboratories, Inc.
9990 Global Rd.
Philadelphia,  PA  19115
Applicant Contact HAROLD STONE
Correspondent
Medical Products Laboratories, Inc.
9990 Global Rd.
Philadelphia,  PA  19115
Correspondent Contact HAROLD STONE
Regulation Number872.3520
Classification Product Code
EFT  
Date Received11/23/1984
Decision Date 01/18/1985
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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