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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, Manual
510(k) Number K940121
Device Name IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS
Applicant
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Applicant Contact SANKARA I RAMASWAMY
Correspondent
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Correspondent Contact SANKARA I RAMASWAMY
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received01/10/1994
Decision Date 12/30/1994
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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