COVER, SHOE OPERATING ROOM— 510(k) K865023

Name: FDA 510(k) clearance K865023
Creator: U.S. Food and Drug Administration
Published: 1987-01-12

Substantially Equivalent

Ulti-Med Intl., Inc.

FDA 510(k) clearance K865023 for COVER, SHOE OPERATING ROOM, Substantially Equivalent on 1987-01-12. Applicant: Ulti-Med Intl., Inc.. Device class: 1.

Clearance details

Applicant: Ulti-Med Intl., Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1986-12-23
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, 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.