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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K934818
Device Name HAND HELD DENTAL X-RAY DEVICE
Applicant
Dept. of the Army
5109 Leesburg Pike
Falls Church,  VA  22041
Applicant Contact DALE G VANDER HAMM
Correspondent
Dept. of the Army
5109 Leesburg Pike
Falls Church,  VA  22041
Correspondent Contact DALE G VANDER HAMM
Regulation Number892.1720
Classification Product Code
IZL  
Date Received10/07/1993
Decision Date 01/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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