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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, impression
510(k) Number K760981
Device Name ALGINATE IMPRESSION MATERIAL
Applicant
ADP INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ADP INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/21/1976
Decision Date 11/15/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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