BRACHYSEED— 510(k) K000475

Substantially Equivalent

Draximage, Inc.

FDA 510(k) clearance K000475 for BRACHYSEED, Substantially Equivalent on 2000-08-22. Applicant: Draximage, Inc.. Device class: 2.

Clearance details

Applicant: Draximage, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2000-02-15
Decision date: 2000-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, Qc, CA

Download summary PDF View on FDA.gov ↗

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