VAGINAL SPECULUM - DISPOSABLE— 510(k) K841909

Name: FDA 510(k) clearance K841909
Creator: U.S. Food and Drug Administration
Published: 1984-07-31

Substantially Equivalent

Galenica Enterprises, Inc.

FDA 510(k) clearance K841909 for VAGINAL SPECULUM - DISPOSABLE, Substantially Equivalent on 1984-07-31. Applicant: Galenica Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Galenica Enterprises, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1984-05-09
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Galenica Enterprises, Inc.

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K883283 — DISPOSABLE AMNIOTOME1988-10-18
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Recalls naming K841909

K-number listed on FDA's recall record

Z-1824-2015 — McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical proceduresClass II·Terminated·CooperSurgical, Inc.·20150413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K841909.

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