THERAFORM STANDARD/SHEET— 510(k) K090812

Name: FDA 510(k) clearance K090812
Creator: U.S. Food and Drug Administration
Published: 2009-07-30

Substantially Equivalent

Sewon Cellontech Co., Ltd.

FDA 510(k) clearance K090812 for THERAFORM STANDARD/SHEET, Substantially Equivalent on 2009-07-30. Applicant: Sewon Cellontech Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Sewon Cellontech Co., Ltd.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2009-03-25
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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K090823 — THERAFORM BILAYER2009-10-22

Adverse events under product code KGN

product code KGN

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.