PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator— 510(k) K162362
Substantially EquivalentPms Tibbi Cihazlar Teknolojisi San VE Tic AS
FDA 510(k) clearance K162362 for PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, Substantially Equivalent on 2017-10-13. Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS.
Clearance details
- Applicant
- Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- 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, through . 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.