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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Wire, Iridium, Radioactive
510(k) Number K874895
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
IWA  
Date Received12/01/1987
Decision Date 02/25/1988
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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