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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Seed, Isotope, Gold, Titanium, Platinum
510(k) Number K982421
Device Name IMAGYN 125 I SEED, MODEL IS 125
Applicant
International Isotopes, Inc.
3100 Jim Christal Rd.
Denton,  TX  76207
Applicant Contact BETSY C KING
Correspondent
International Isotopes, Inc.
3100 Jim Christal Rd.
Denton,  TX  76207
Correspondent Contact BETSY C KING
Regulation Number892.5730
Classification Product Code
IWG  
Date Received07/13/1998
Decision Date 07/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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