K160595

Substantially Equivalent

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Applicant: Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
Product code: FRG
Advisory panel: General Hospital
Date received: 2016-03-01
Decision date: 2016-11-18
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.