K861525

Substantially Equivalent

DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS

Applicant
D & D Products, Inc.
Product code
FSM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Long Beach, CA, US
Download summary PDF View on FDA.gov ↗

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.