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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 K923697
Device Name RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
Applicant
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/24/1992
Decision Date 12/13/1993
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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