MucoPEG— 510(k) K190144

Substantially Equivalent

Sunbio, Inc.

FDA 510(k) clearance K190144 for MucoPEG, Substantially Equivalent on 2019-11-05. Applicant: Sunbio, Inc..

Clearance details

Applicant: Sunbio, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2019-01-29
Decision date: 2019-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

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.