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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 K973744
Device Name UNICATH SP BI-PLANE (MODEL M269 & M289)
Applicant
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Applicant Contact WAYNE V LOOMER
Correspondent
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact WAYNE V LOOMER
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received10/01/1997
Decision Date 12/29/1997
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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