PEDERSON VAGINAL SPECULA— 510(k) K821291

Name: FDA 510(k) clearance K821291
Creator: U.S. Food and Drug Administration
Published: 1982-05-24

Substantially Equivalent

Conphar, Inc.

FDA 510(k) clearance K821291 for PEDERSON VAGINAL SPECULA, Substantially Equivalent on 1982-05-24. Applicant: Conphar, Inc.. Device class: 1.

Clearance details

Applicant: Conphar, Inc.
Product code: Code HDF
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1982-05-04
Decision date: 1982-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HDF

product code HDF

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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