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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K896197
Device Name COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
Applicant
Colab Intl., Inc.
Suite 100
3839 Ulloa St.
New Orleans,  LA  70119
Applicant Contact MORGAN, M.D.
Correspondent
Colab Intl., Inc.
Suite 100
3839 Ulloa St.
New Orleans,  LA  70119
Correspondent Contact MORGAN, M.D.
Regulation Number892.5730
Classification Product Code
KXK  
Date Received10/27/1989
Decision Date 07/11/1990
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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