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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Color
510(k) Number K770667
Device Name CHROMASCAN TM
Applicant
STERNDENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STERNDENT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3661
Classification Product Code
KZN  
Date Received04/08/1977
Decision Date 04/20/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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