BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT— 510(k) K845038

Name: FDA 510(k) clearance K845038
Creator: U.S. Food and Drug Administration
Published: 1985-03-11

Substantially Equivalent

Ranfac, Corp.

FDA 510(k) clearance K845038 for BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT, Substantially Equivalent on 1985-03-11. Applicant: Ranfac, Corp.. Device class: 1.

Clearance details

Applicant: Ranfac, Corp.
Product code: Code GDF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-12-27
Decision date: 1985-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.