SOM 6V— 510(k) K910357

Name: FDA 510(k) clearance K910357
Creator: U.S. Food and Drug Administration
Published: 1991-02-19

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K910357 for SOM 6V, Substantially Equivalent on 1991-02-19. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code FSO
Device class: Class 1
Regulation: 21 CFR 878.4700
Advisory panel: General, Plastic Surgery
Date received: 1991-01-29
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FSO

product code FSO

Other: 1
Total: 1

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.