GENT-L-SPEC DISPOS. VAGINAL SPECULUM— 510(k) K830725

Name: FDA 510(k) clearance K830725
Creator: U.S. Food and Drug Administration
Published: 1983-04-27

Substantially Equivalent

Geneva Laboratories, Inc.

FDA 510(k) clearance K830725 for GENT-L-SPEC DISPOS. VAGINAL SPECULUM, Substantially Equivalent on 1983-04-27. Applicant: Geneva Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Geneva Laboratories, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1983-03-08
Decision date: 1983-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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