DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL— 510(k) K960815

Clearance details

Applicant

Dumex Medical Surgical Products, Ltd.

Product code

Code NAD

Device class

Class 1

Regulation

21 CFR 878.4020

Advisory panel

General, Plastic Surgery

Date received

1996-02-28

Decision date

1996-04-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Toronto, Orntario, CA

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Injury

431

Malfunction

11,935

Other

1

Total

12,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →