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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 K860737
Device Name TEEN CLEAN, RETAINER CLEANER
Applicant
Teen Care, Inc.
Stuart Lee Friedel
850 Third Ave.
New York,  NY  10022
Applicant Contact & GILBERT
Correspondent
Teen Care, Inc.
Stuart Lee Friedel
850 Third Ave.
New York,  NY  10022
Correspondent Contact & GILBERT
Regulation Number872.3520
Classification Product Code
EFT  
Date Received02/27/1986
Decision Date 03/26/1986
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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