`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH— 510(k) K984446

Name: FDA 510(k) clearance K984446
Creator: U.S. Food and Drug Administration
Published: 1999-04-16

Substantially Equivalent

Urocor, Inc.

FDA 510(k) clearance K984446 for `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH, Substantially Equivalent on 1999-04-16. Applicant: Urocor, Inc.. Device class: 2.

Clearance details

Applicant: Urocor, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1998-12-14
Decision date: 1999-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

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