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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 K760231
Device Name IMPRESSION MATERIAL, DENTAL SILICON RTV
Applicant
Crown Delta Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Crown Delta Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/14/1976
Decision Date 07/21/1976
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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