AMSure Sterile Water, and Sterile Normal Saline for Wound Flush— 510(k) K181423
Substantially EquivalentAmsino International, Inc.
FDA 510(k) clearance K181423 for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush, Substantially Equivalent on 2018-09-07. Applicant: Amsino International, Inc..
Clearance details
- Applicant
- Amsino International, Inc.
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pomona, CA, US
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.