STERILIZATION POUCH WITH INDICATORS— 510(k) K062704

Substantially Equivalent

Winner Industries (Shenzhen) Co., Ltd.

FDA 510(k) clearance K062704 for STERILIZATION POUCH WITH INDICATORS, Substantially Equivalent on 2007-06-08. Applicant: Winner Industries (Shenzhen) Co., Ltd..

Clearance details

Applicant: Winner Industries (Shenzhen) Co., Ltd.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2006-09-11
Decision date: 2007-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.