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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, Manual
510(k) Number K940550
Device Name COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
Applicant
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Correspondent Contact APRIL LAVENDER
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received02/07/1994
Decision Date 08/17/1994
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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