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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 K896024
Device Name MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
Applicant
Mdt Diagnostic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Applicant Contact R CATT
Correspondent
Mdt Diagnostic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Correspondent Contact R CATT
Regulation Number872.1810
Classification Product Code
EAP  
Date Received10/16/1989
Decision Date 01/22/1990
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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