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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K850605
Device Name RADI-BIOPSY DEVICE
Applicant
Radiplast AB
Attorney & Counselor At Law
715 American National Bank Bld
Kalamazoo,  MI  49007
Applicant Contact GORDON W HUESCHENCH
Correspondent
Radiplast AB
Attorney & Counselor At Law
715 American National Bank Bld
Kalamazoo,  MI  49007
Correspondent Contact GORDON W HUESCHENCH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/15/1985
Decision Date 08/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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