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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 K920431
Device Name OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE
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 Received02/03/1992
Decision Date 05/29/1992
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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