CYTOGUIDE STEREOTATIC BIOPSY SYSTEM— 510(k) K933430

Name: FDA 510(k) clearance K933430
Creator: U.S. Food and Drug Administration
Published: 1994-09-22

Substantially Equivalent

Gold Coast Imaging, Inc.

FDA 510(k) clearance K933430 for CYTOGUIDE STEREOTATIC BIOPSY SYSTEM, Substantially Equivalent on 1994-09-22. Applicant: Gold Coast Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Gold Coast Imaging, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1993-07-13
Decision date: 1994-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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