HEMCON CHITOFLEX-SURGICAL DRESSING— 510(k) K071519

Name: FDA 510(k) clearance K071519
Creator: U.S. Food and Drug Administration
Published: 2007-08-06

Substantially Equivalent

Hemcon, Inc.

FDA 510(k) clearance K071519 for HEMCON CHITOFLEX-SURGICAL DRESSING, Substantially Equivalent on 2007-08-06. Applicant: Hemcon, Inc.. Device class: Unclassified.

Clearance details

Applicant: Hemcon, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2007-06-04
Decision date: 2007-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hemcon, Inc.

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K060363 — HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 122006-07-07
K043050 — HEMCON BANDAGE AND HEMCON BANDAGE OTC2005-06-03
K030946 — HEMCON BANDAGE OTC; HEMCON CATH/AID2003-06-19
K023298 — HEMCON BANDAGE2002-11-04

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.