BIOLUCENT MAMMOGRAPHY CUSHION— 510(k) K003795

Substantially Equivalent

Biolucent, Inc.

FDA 510(k) clearance K003795 for BIOLUCENT MAMMOGRAPHY CUSHION, Substantially Equivalent on 2001-02-14. Applicant: Biolucent, Inc.. Device class: 2.

Clearance details

Applicant: Biolucent, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2000-12-08
Decision date: 2001-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biolucent, Inc.

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K061241 — BIOLUCENT APPLICATOR, MODEL RTA-XX2006-07-28
K053595 — CURAY CUSTOM SEED ARRAY2006-02-28

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