CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL— 510(k) K133764

Substantially Equivalent

Avery Dennison Belgie Bvba

FDA 510(k) clearance K133764 for CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL, Substantially Equivalent on 2014-03-13. Applicant: Avery Dennison Belgie Bvba.

Clearance details

Applicant: Avery Dennison Belgie Bvba
Product code: Code FRO
Advisory panel: Unknown
Date received: 2013-12-11
Decision date: 2014-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Turnhout, BE

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.