MASK, SURGICAL APPAREL— 510(k) K911334

Substantially Equivalent

Thai Hospital Products Co., Ltd.

FDA 510(k) clearance K911334 for MASK, SURGICAL APPAREL, Substantially Equivalent on 1991-08-29. Applicant: Thai Hospital Products Co., Ltd..

Clearance details

Applicant: Thai Hospital Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1991-03-26
Decision date: 1991-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prachinburi, TH

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.