PHARMA-PLAST SINGLE USE OVERSHOES— 510(k) K843475

Name: FDA 510(k) clearance K843475
Creator: U.S. Food and Drug Administration
Published: 1984-10-31

Substantially Equivalent

Zimmar Consulting , Ltd.

FDA 510(k) clearance K843475 for PHARMA-PLAST SINGLE USE OVERSHOES, Substantially Equivalent on 1984-10-31. Applicant: Zimmar Consulting , Ltd.. Device class: 1.

Clearance details

Applicant: Zimmar Consulting , Ltd.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1984-09-06
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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