POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS— 510(k) K925077

Name: FDA 510(k) clearance K925077
Creator: U.S. Food and Drug Administration
Published: 1993-08-16

Substantially Equivalent

Medtek Development Corp.

FDA 510(k) clearance K925077 for POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS, Substantially Equivalent on 1993-08-16. Applicant: Medtek Development Corp.. Device class: 2.

Clearance details

Applicant: Medtek Development Corp.
Product code: Code FYC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1992-10-07
Decision date: 1993-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IL, US

Download summary PDF View on FDA.gov ↗

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