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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 K844337
Device Name X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY
Applicant
Quality X-Ray Manufacturing, Inc.
746 Galloway
Memphis,  TN  38105
Applicant Contact DANIEL I FREEMAN
Correspondent
Quality X-Ray Manufacturing, Inc.
746 Galloway
Memphis,  TN  38105
Correspondent Contact DANIEL I FREEMAN
Regulation Number892.1770
Classification Product Code
IYB  
Date Received11/08/1984
Decision Date 02/21/1985
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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