MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE— 510(k) K052704

Name: FDA 510(k) clearance K052704
Creator: U.S. Food and Drug Administration
Published: 2005-11-03

Substantially Equivalent

Invivo Corp.

FDA 510(k) clearance K052704 for MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE, Substantially Equivalent on 2005-11-03. Applicant: Invivo Corp.. Device class: 2.

Clearance details

Applicant: Invivo Corp.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2005-09-28
Decision date: 2005-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pewaukee, WI, US

Download summary PDF View on FDA.gov ↗

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