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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 K972554
Device Name REGANES RADIONUCLIDE SEED MAGAZINE
Applicant
Avid N.I.T., Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
Avid N.I.T., Inc.
917 Klosterman Rd.E
Tarpon Springs,  FL  34689
Correspondent Contact JOSEPH E HARMS
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received07/08/1997
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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