RADIOACTIVE SEED LOCALIZATION NEEDLE— 510(k) K111979

Name: FDA 510(k) clearance K111979
Creator: U.S. Food and Drug Administration
Published: 2011-10-18

Substantially Equivalent

Biocompatibles, Inc.

FDA 510(k) clearance K111979 for RADIOACTIVE SEED LOCALIZATION NEEDLE, Substantially Equivalent on 2011-10-18. Applicant: Biocompatibles, Inc.. Device class: 2.

Clearance details

Applicant: Biocompatibles, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2011-07-12
Decision date: 2011-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

Download summary PDF View on FDA.gov ↗

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