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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 K992262
Device Name INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
Applicant
Indigo Medical, Inc.
10123 Alliance Rd.
Cincinnati,  OH  45242
Applicant Contact JACQUELYN A HUGHES
Correspondent
Indigo Medical, Inc.
10123 Alliance Rd.
Cincinnati,  OH  45242
Correspondent Contact JACQUELYN A HUGHES
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/06/1999
Decision Date 10/04/1999
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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