DERMASSIST WET DRESSING, WATER— 510(k) K940076

Name: FDA 510(k) clearance K940076
Creator: U.S. Food and Drug Administration
Published: 1994-03-03

Substantially Equivalent

Wilshire Medical Products

FDA 510(k) clearance K940076 for DERMASSIST WET DRESSING, WATER, Substantially Equivalent on 1994-03-03. Applicant: Wilshire Medical Products. Device class: Unclassified.

Clearance details

Applicant: Wilshire Medical Products
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-01-06
Decision date: 1994-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K944333 — HYDRODERM GEL WOUND DRESSING1994-11-10
K941149 — DERMAASSIST HYDROCOLLOID DRESSING1994-05-20
K941216 — HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING1994-05-20

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.