DISPOSABLE PLASTIC VAGINAL SPECULUM— 510(k) K903080

Name: FDA 510(k) clearance K903080
Creator: U.S. Food and Drug Administration
Published: 1990-09-19

Substantially Equivalent

Dawnex Industries, Inc.

FDA 510(k) clearance K903080 for DISPOSABLE PLASTIC VAGINAL SPECULUM, Substantially Equivalent on 1990-09-19. Applicant: Dawnex Industries, Inc.. Device class: 2.

Clearance details

Applicant: Dawnex Industries, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1990-07-12
Decision date: 1990-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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