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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 K923130
Device Name IR-192 IMPLANT -- MODIFICATION
Applicant
Omnitron Intl., Inc.
P.O. Box 5247
3409 W. Prie Lake Rd.
Lajke Charles,  LA  70606
Correspondent
Omnitron Intl., Inc.
P.O. Box 5247
3409 W. Prie Lake Rd.
Lajke Charles,  LA  70606
Regulation Number892.5730
Classification Product Code
KXK  
Date Received06/25/1992
Decision Date 09/21/1992
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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