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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 K931393
FOIA Releasable 510(k) K931393
Device Name BEBIG PLAQUES RUM101-RUM114
Applicant
Bebig, Inc.
65 Cooper Sq.
#4
New York,  NY  10003
Applicant Contact DR. A ECKERT
Correspondent
Bebig, Inc.
65 Cooper Sq.
#4
New York,  NY  10003
Correspondent Contact DR. A ECKERT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/19/1993
Decision Date 03/16/1994
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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