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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Wire, Iridium, Radioactive
510(k) Number K850163
Device Name IRIDIUM 192 WIRES
Applicant
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Correspondent Contact ELEANOR V CHIU
Regulation Number892.5730
Classification Product Code
IWA  
Date Received01/16/1985
Decision Date 03/26/1985
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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