VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L— 510(k) K022948

Name: FDA 510(k) clearance K022948
Creator: U.S. Food and Drug Administration
Published: 2002-11-04

Substantially Equivalent

Medical Action Industries, Inc.

FDA 510(k) clearance K022948 for VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L, Substantially Equivalent on 2002-11-04. Applicant: Medical Action Industries, Inc.. Device class: 2.

Clearance details

Applicant: Medical Action Industries, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2002-09-05
Decision date: 2002-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden, NC, US

Download summary PDF View on FDA.gov ↗

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