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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Denture, Over The Counter
510(k) Number K813190
Device Name SOFT PLATE CUSHION
Applicant
Leonard Russo Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Leonard Russo Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3540
Classification Product Code
EHS  
Date Received11/16/1981
Decision Date 02/05/1982
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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