BREAST LESION LOCALIZATION NEEDLE— 510(k) K944942

Name: FDA 510(k) clearance K944942
Creator: U.S. Food and Drug Administration
Published: 1994-11-04

Substantially Equivalent

Promedical , Ltd.

FDA 510(k) clearance K944942 for BREAST LESION LOCALIZATION NEEDLE, Substantially Equivalent on 1994-11-04. Applicant: Promedical , Ltd.. Device class: 1.

Clearance details

Applicant: Promedical , Ltd.
Product code: Code GDF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1994-10-07
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyckoff, NJ, US

Download summary PDF View on FDA.gov ↗

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