IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM— 510(k) K010166

Name: FDA 510(k) clearance K010166
Creator: U.S. Food and Drug Administration
Published: 2001-12-03

Substantially Equivalent

Imagyn Medical Technologies, Inc.

FDA 510(k) clearance K010166 for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM, Substantially Equivalent on 2001-12-03. Applicant: Imagyn Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Imagyn Medical Technologies, Inc.
Product code: Code IWJ
Device class: Class 1
Regulation: 21 CFR 892.5650
Advisory panel: Radiology
Date received: 2001-01-18
Decision date: 2001-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

Download summary PDF View on FDA.gov ↗

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