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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K851733
Device Name DENTAL PORCELAIN-VARIOUS
Applicant
Excelco Intl., Inc.
P.O. Box 13097 Santurce
Puerto Rico, 
Applicant Contact WARREN HERBSTAMAN
Correspondent
Excelco Intl., Inc.
P.O. Box 13097 Santurce
Puerto Rico, 
Correspondent Contact WARREN HERBSTAMAN
Regulation Number872.3920
Classification Product Code
ELL  
Date Received04/25/1985
Decision Date 10/16/1985
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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