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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic, Dental
510(k) Number K992896
Device Name DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
Applicant
Dental X-Ray Support Systems, Inc.
2124 - 196th St. SW, Suite B
Lynnwood,  WA  98036
Applicant Contact JUM JACOBSON
Correspondent
Dental X-Ray Support Systems, Inc.
2124 - 196th St. SW, Suite B
Lynnwood,  WA  98036
Correspondent Contact JUM JACOBSON
Regulation Number892.1900
Classification Product Code
EGY  
Date Received08/27/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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