STERILE LACERATION TRAY CAT. #749— 510(k) K900479
Substantially EquivalentBusse Hospital Disposables, Inc.
FDA 510(k) clearance K900479 for STERILE LACERATION TRAY CAT. #749, Substantially Equivalent on 1990-02-13. Applicant: Busse Hospital Disposables, Inc..
Clearance details
- Applicant
- Busse Hospital Disposables, Inc.
- Product code
- Code FSM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Adverse events under product code FSM
product code FSM- Malfunction
- 1,289
- Total
- 1,289
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.