OPERATING ROOM KIT— 510(k) K811916
Substantially EquivalentAmerican Hospital Supply Corp.
FDA 510(k) clearance K811916 for OPERATING ROOM KIT, Substantially Equivalent on 1981-10-14. Applicant: American Hospital Supply Corp..
Clearance details
- Applicant
- American Hospital Supply Corp.
- Product code
- Code FSM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.