(DISPOSABLE) VAGINAL SPECULUM— 510(k) K003540

Substantially Equivalent

Feminica, Inc.

FDA 510(k) clearance K003540 for (DISPOSABLE) VAGINAL SPECULUM, Substantially Equivalent on 2001-02-09. Applicant: Feminica, Inc.. Device class: 2.

Clearance details

Applicant: Feminica, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2000-11-16
Decision date: 2001-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Quebec, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.