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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K923738
Device Name HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
Applicant
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received07/27/1992
Decision Date 04/13/1993
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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