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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cleaner, Denture, Mechanical
510(k) Number K872521
Device Name DENTURE CLEANSERS
Applicant
Dental Research Laboratories
3095 Enisglen Dr.
Palm Harbor,  FL  33563
Applicant Contact GARBLIK, DDS
Correspondent
Dental Research Laboratories
3095 Enisglen Dr.
Palm Harbor,  FL  33563
Correspondent Contact GARBLIK, DDS
Regulation Number872.3530
Classification Product Code
JER  
Date Received06/25/1987
Decision Date 08/11/1987
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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