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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, Fluoroscopic, Image-Intensified
510(k) Number K992603
Device Name XRT 600 R/F, WRF 0600
Applicant
Wuestec Medical, Inc.
5600 Commerce Blvd., E.
Mobile,  AL  36619
Applicant Contact BRENDA S DAVIS
Correspondent
Wuestec Medical, Inc.
5600 Commerce Blvd., E.
Mobile,  AL  36619
Correspondent Contact BRENDA S DAVIS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/03/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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