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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K913908
Device Name OMNITRON GYN APPLICATOR SYSTEM
Applicant
Omnitron Intl., Inc.
8990 Kirby, Suite 200
Houston,  TX  77054
Applicant Contact LISA S JONES
Correspondent
Omnitron Intl., Inc.
8990 Kirby, Suite 200
Houston,  TX  77054
Correspondent Contact LISA S JONES
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/30/1991
Decision Date 03/06/1992
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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