CURAY CUSTOM SEED ARRAY— 510(k) K053595

Substantially Equivalent

Biolucent, Inc.

FDA 510(k) clearance K053595 for CURAY CUSTOM SEED ARRAY, Substantially Equivalent on 2006-02-28. Applicant: Biolucent, Inc.. Device class: 2.

Clearance details

Applicant: Biolucent, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2005-12-23
Decision date: 2006-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.