BANDAGE— 510(k) K761093

Clearance details

Applicant

Paco Pharmaceutical Services, Inc.

Product code

Code NAD

Device class

Class 1

Regulation

21 CFR 878.4020

Advisory panel

General, Plastic Surgery

Date received

1976-11-22

Decision date

1977-01-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lakewood, NJ, US

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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 →