PREVANTICS DEVICE SWAB— 510(k) K132380
Substantially EquivalentProfessional Disposables International, Inc.
FDA 510(k) clearance K132380 for PREVANTICS DEVICE SWAB, Substantially Equivalent on 2014-08-27. Applicant: Professional Disposables International, Inc..
Clearance details
- Applicant
- Professional Disposables International, Inc.
- Product code
- Code LKB
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Adverse events under product code LKB
product code LKB- Other
- 2
- Total
- 2
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.