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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, Angiographic
510(k) Number K892849
Device Name UNICATH A
Applicant
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Applicant Contact THOMAS F FLYNN
Correspondent
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact THOMAS F FLYNN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received04/18/1989
Decision Date 08/09/1989
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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