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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 K945983
Device Name BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
Applicant
Bebig Trade, Inc.
100 W. Monroe St., Suite 1101
Chicago,  IL  60603
Applicant Contact PETER U NILSEN
Correspondent
Bebig Trade, Inc.
100 W. Monroe St., Suite 1101
Chicago,  IL  60603
Correspondent Contact PETER U NILSEN
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/08/1994
Decision Date 10/18/1995
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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