ELASTIC BREATHABLE OVER-WRAP BANDAGE— 510(k) K833729

Clearance details

Applicant

American Medical Disposable, Inc.

Product code

Code NAD

Device class

Class 1

Regulation

21 CFR 878.4020

Advisory panel

General, Plastic Surgery

Date received

1983-10-25

Decision date

1983-12-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K254246 — LT Antibacterial Foam with Silver Dressing2026-09-10
• K102403 — SAM CHEST SEAL WITH VAVLE2011-03-03
• K091133 — APLION TOPICAL CARE SYSTEM2009-05-20
• K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)2008-06-17
• K080524 — CENTURION SORBAVIEW OTC2008-04-23

• K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK1984-04-23
• K833735 — AN ODOR ABSORBENT BANDAGE1984-04-23
• K833730 — NON ADHERENT BANDAGE/SHEET1984-01-27
• K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS1984-01-27
• K833733 — NON - ADHERENT BANDAGE1983-12-27

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 →