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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, Extraoral With Timer
510(k) Number K000061
Device Name MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
Applicant
MINXRAY, INC.
3611 COMMERCIAL AVE.
NORTHBROOK,  IL  60062
Applicant Contact KEITH KRETCHMER
Correspondent
MINXRAY, INC.
3611 COMMERCIAL AVE.
NORTHBROOK,  IL  60062
Correspondent Contact KEITH KRETCHMER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/10/2000
Decision Date 04/07/2000
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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