K162362

Substantially Equivalent

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
Product code: FRG
Advisory panel: General Hospital
Date received: 2016-08-23
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mersin, TR

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.