510(k) K072930— DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT

Substantially Equivalent

Demetech Corp.

Clearance details

Applicant: Demetech Corp.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 2007-10-16
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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.