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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 K942203
Device Name OTC DENTURE CLEANSER
Applicant
Combe, Inc.
1101 Westchester Ave.
White Plains,  NY  10604
Applicant Contact STEPHEN C PENNISI
Correspondent
Combe, Inc.
1101 Westchester Ave.
White Plains,  NY  10604
Correspondent Contact STEPHEN C PENNISI
Regulation Number872.3520
Classification Product Code
EFT  
Date Received05/05/1994
Decision Date 08/10/1994
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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