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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K882379
Device Name MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
Applicant
Dentomar, Inc.
72 Peppertree Dr.
Palatine,  IL  60067
Applicant Contact ED SLAGIS
Correspondent
Dentomar, Inc.
72 Peppertree Dr.
Palatine,  IL  60067
Correspondent Contact ED SLAGIS
Regulation Number872.1810
Classification Product Code
EAP  
Date Received06/09/1988
Decision Date 09/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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