KIMGUARD ONE-STEP Sterilization Wrap— 510(k) K143053
Substantially EquivalentKimberly-Clark Health Care
FDA 510(k) clearance K143053 for KIMGUARD ONE-STEP Sterilization Wrap, Substantially Equivalent on 2015-04-03. Applicant: Kimberly-Clark Health Care.
Clearance details
- Applicant
- Kimberly-Clark Health Care
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
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.