PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator— 510(k) K160595
Substantially EquivalentPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
FDA 510(k) clearance K160595 for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator, Substantially Equivalent on 2016-11-18. Applicant: Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti.
Clearance details
- Applicant
- Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
- 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.