WOUND DRESSING/ABD PAD, MODEL #10810— 510(k) K990861

Substantially Equivalent

Hospital Specialty Co.

FDA 510(k) clearance K990861 for WOUND DRESSING/ABD PAD, MODEL #10810, Substantially Equivalent on 1999-04-12. Applicant: Hospital Specialty Co..

Clearance details

Applicant
Hospital Specialty Co.
Product code
Code NAD
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cleveland, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NAD

product code NAD
Injury
431
Malfunction
11,935
Other
1
Total
12,367

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.