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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 K872240
Device Name PORTABLE DENTAL X-RAY UNIT MODEL 4000
Applicant
Home/Office Dental, Inc.
6726 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact RAYMOND D ELLIOTT
Correspondent
Home/Office Dental, Inc.
6726 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact RAYMOND D ELLIOTT
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/11/1987
Decision Date 07/16/1987
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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