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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 K922117
Device Name C-TRAK BIOPSY SYSTEM
Applicant
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Applicant Contact WISE, JR.
Correspondent
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Correspondent Contact WISE, JR.
Regulation Number892.1320
Classification Product Code
IZD  
Date Received05/05/1992
Decision Date 10/14/1992
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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