AILEE SUTURES AND AILEE NEEDLES— 510(k) K982646

Substantially Equivalent

Myco Medical Supplies, Inc.

FDA 510(k) clearance K982646 for AILEE SUTURES AND AILEE NEEDLES, Substantially Equivalent on 1999-06-02. Applicant: Myco Medical Supplies, Inc..

Clearance details

Applicant: Myco Medical Supplies, Inc.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 1998-07-29
Decision date: 1999-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cary, NC, US

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Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.