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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K935004
Device Name MODEL ALPHA TS-2
Applicant
Dpa Consulting, Inc.
Box 786
Urbanna,  VA  23175
Applicant Contact DAVID P ARMSTRONG
Correspondent
Dpa Consulting, Inc.
Box 786
Urbanna,  VA  23175
Correspondent Contact DAVID P ARMSTRONG
Regulation Number892.1770
Classification Product Code
IYB  
Date Received10/19/1993
Decision Date 12/13/1993
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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