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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 K915253
Device Name IR-192 IMPLANT, MODIFICATION
Applicant
Omnitron Intl., Inc.
P.O. Box 5247
3409 W. Prie Lake Rd.
Lajke Charles,  LA  70606
Applicant Contact SAM F LIPRIE
Correspondent
Omnitron Intl., Inc.
P.O. Box 5247
3409 W. Prie Lake Rd.
Lajke Charles,  LA  70606
Correspondent Contact SAM F LIPRIE
Regulation Number892.5730
Classification Product Code
IWA  
Date Received11/18/1991
Decision Date 02/27/1992
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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