Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators— 510(k) K153540
Substantially EquivalentSafe Secure Packaging Co., Ltd.
FDA 510(k) clearance K153540 for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, Substantially Equivalent on 2016-08-04. Applicant: Safe Secure Packaging Co., Ltd..
Clearance details
- Applicant
- Safe Secure Packaging Co., Ltd.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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.