SURGICAL BANDAGES/SUNLEEP DX— 510(k) K801840

Name: FDA 510(k) clearance K801840
Creator: U.S. Food and Drug Administration
Published: 1980-09-09

Substantially Equivalent

Martin'S Maine Exchange

FDA 510(k) clearance K801840 for SURGICAL BANDAGES/SUNLEEP DX, Substantially Equivalent on 1980-09-09. Applicant: Martin'S Maine Exchange. Device class: 1.

Clearance details

Applicant: Martin'S Maine Exchange
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
Advisory panel: General, Plastic Surgery
Date received: 1980-08-01
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAD

view all

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

More clearances from Martin'S Maine Exchange

view all

K810008 — ALP-KII1981-01-16
K801837 — PLASTIC STRIP BANDAGES1980-10-31
K801839 — DISPOSABLE HYPODERMIC NEEDLES1980-09-16

Adverse events under product code NAD

product code NAD

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.