ADHESIVE STRIP(MULTIPLE)— 510(k) K813361

Name: FDA 510(k) clearance K813361
Creator: U.S. Food and Drug Administration
Published: 1982-01-18

Substantially Equivalent

Cederroth, Inc. USA

FDA 510(k) clearance K813361 for ADHESIVE STRIP(MULTIPLE), Substantially Equivalent on 1982-01-18. Applicant: Cederroth, Inc. USA. Device class: 1.

Clearance details

Applicant: Cederroth, Inc. USA
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1981-11-30
Decision date: 1982-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cederroth, Inc. USA

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K880788 — NON ADHERENT PAD1988-04-01
K823057 — MEDICATED ADHESIVE STRIP1983-03-31
K830330 — SAVETT ALCOHOL PREP1983-03-17
K820059 — RESUSCITATION MASK1982-03-26
K813365 — MULTIPLE BANDAGE OR DRESSING1982-02-04

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.