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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, Mammographic
510(k) Number K890483
Device Name THE PATHFINDER SYSTEM
Applicant
Denmark Assoc.
P.O.B. 10341
Bowling Green,  KY  42102
Applicant Contact ALBERHASKY, MD
Correspondent
Denmark Assoc.
P.O.B. 10341
Bowling Green,  KY  42102
Correspondent Contact ALBERHASKY, MD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/31/1989
Decision Date 03/14/1989
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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