GILTECH PLUS TRANSPARENT DRESSING— 510(k) K992005

Name: FDA 510(k) clearance K992005
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Giltech Plus, Inc.

FDA 510(k) clearance K992005 for GILTECH PLUS TRANSPARENT DRESSING, Substantially Equivalent on 1999-09-03. Applicant: Giltech Plus, Inc.. Device class: Unclassified.

Clearance details

Applicant: Giltech Plus, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-06-15
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, PA, US

Download summary PDF View on FDA.gov ↗

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K001508 — LASERSKIN DRESSING2001-07-25
K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Giltech Plus, Inc.

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K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING1999-09-17
K983624 — GILTECH PLUS CONNECTING TUBE SET1999-03-18

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

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.