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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 K001070
Device Name RADIOMED SOURCE
Applicant
Radiomed Corp.
9 Linnell Circle
Billerica,  MA  01821
Applicant Contact JOHN SCHWAMB
Correspondent
Radiomed Corp.
9 Linnell Circle
Billerica,  MA  01821
Correspondent Contact JOHN SCHWAMB
Regulation Number892.5730
Classification Product Code
KXK  
Date Received04/03/2000
Decision Date 10/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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