K984370

Substantially Equivalent

HYPERGEL 20% HYPERTONIC SALINE GEL

Applicant: Molnlycke Health Care, Inc.
Product code: MGQ
Advisory panel: Unknown
Date received: 1998-12-07
Decision date: 1999-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eddystone, PA, US

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.