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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K896588
Device Name ONCOPROBE II SYSTEM
Applicant
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Applicant Contact LINDA P CARROLL,PHD
Correspondent
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Correspondent Contact LINDA P CARROLL,PHD
Regulation Number892.1320
Classification Product Code
IZD  
Date Received11/21/1989
Decision Date 03/14/1990
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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