GEL-TAC(R)— 510(k) K895009

Name: FDA 510(k) clearance K895009
Creator: U.S. Food and Drug Administration
Published: 1989-12-13

Substantially Equivalent

Padeco, Inc.

FDA 510(k) clearance K895009 for GEL-TAC(R), Substantially Equivalent on 1989-12-13. Applicant: Padeco, Inc.. Device class: 2.

Clearance details

Applicant: Padeco, Inc.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1989-08-08
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.