BIMECO FILTERED EXTENSION SET— 510(k) K801605
Substantially EquivalentBurron Medical Products, Inc.
FDA 510(k) clearance K801605 for BIMECO FILTERED EXTENSION SET, Substantially Equivalent on 1980-08-12. Applicant: Burron Medical Products, Inc..
Clearance details
- Applicant
- Burron Medical Products, Inc.
- Product code
- Code FPB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FPB
product code FPB- 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.