BREAST LESION LOCALIZATION NEEDLE— 510(k) K881697

Name: FDA 510(k) clearance K881697
Creator: U.S. Food and Drug Administration
Published: 1988-09-14

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K881697 for BREAST LESION LOCALIZATION NEEDLE, Substantially Equivalent on 1988-09-14. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1988-04-19
Decision date: 1988-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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