MEDISURF— 510(k) K971347

Substantially Equivalent

International Regulatory Consultants

FDA 510(k) clearance K971347 for MEDISURF, Substantially Equivalent on 1997-07-03. Applicant: International Regulatory Consultants. Device class: 1.

Clearance details

Applicant: International Regulatory Consultants
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-04-10
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

Download summary PDF View on FDA.gov ↗

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