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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 K903465
Device Name IR-192 IMPLANT
Applicant
Rads S.L., Inc.
P.O. Box 834
Lake Charles,  LA  70602
Applicant Contact SAM F.LIPRIE
Correspondent
Rads S.L., Inc.
P.O. Box 834
Lake Charles,  LA  70602
Correspondent Contact SAM F.LIPRIE
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/01/1990
Decision Date 10/12/1990
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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