ARTHRO-PREP REST— 510(k) K812396
Substantially EquivalentNorthwest Surgical Concepts, Inc.
FDA 510(k) clearance K812396 for ARTHRO-PREP REST, Substantially Equivalent on 1981-11-20. Applicant: Northwest Surgical Concepts, Inc..
Clearance details
- Applicant
- Northwest Surgical Concepts, Inc.
- Product code
- Code BWN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code BWN
product code BWN- Other
- 1
- Total
- 1
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.