CARETEX SKID RESISTANT SHOE COVERS— 510(k) K880093

Name: FDA 510(k) clearance K880093
Creator: U.S. Food and Drug Administration
Published: 1988-01-29

Substantially Equivalent

James River Corp.

FDA 510(k) clearance K880093 for CARETEX SKID RESISTANT SHOE COVERS, Substantially Equivalent on 1988-01-29. Applicant: James River Corp.. Device class: 1.

Clearance details

Applicant: James River Corp.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1988-01-12
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, US

Download summary PDF View on FDA.gov ↗

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K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19

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