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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 K881665
Device Name OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
Applicant
Omnitron Intl., Inc.
3839 Ulloa St.
Suite 100
New Orleans,  LA  70119
Applicant Contact KATHLEEN W JUDGE
Correspondent
Omnitron Intl., Inc.
3839 Ulloa St.
Suite 100
New Orleans,  LA  70119
Correspondent Contact KATHLEEN W JUDGE
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received04/18/1988
Decision Date 08/11/1988
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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