PROCEL BURN COVER/PROCEL BURN TREATMENT COVER— 510(k) K943280
Substantially Equivalent for Some IndicationsW.L. Gore & Company, GmbH
FDA 510(k) clearance K943280 for PROCEL BURN COVER/PROCEL BURN TREATMENT COVER, Substantially Equivalent for Some Indications on 1994-08-18. Applicant: W.L. Gore & Company, GmbH.
Clearance details
- Applicant
- W.L. Gore & Company, GmbH
- Product code
- Code MGP
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Putzbrunn, DE
Adverse events under product code MGP
product code MGP- 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.