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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K860203
Device Name TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
Applicant
Tingle X-Ray Products, Inc.
10629 Txr Rd.
Vance,  AL  35490
Applicant Contact JERRY M TINGLE
Correspondent
Tingle X-Ray Products, Inc.
10629 Txr Rd.
Vance,  AL  35490
Correspondent Contact JERRY M TINGLE
Regulation Number892.1700
Classification Product Code
IZO  
Date Received01/22/1986
Decision Date 01/30/1986
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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