SIGMA Sterilization Pouch and Roll— 510(k) K180661
Substantially EquivalentSigma Medical Supplies Corp.
FDA 510(k) clearance K180661 for SIGMA Sterilization Pouch and Roll, Substantially Equivalent on 2018-06-05. Applicant: Sigma Medical Supplies Corp..
Clearance details
- Applicant
- Sigma Medical Supplies Corp.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- New Taipei City, TW
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.