POSE™ Health Care Surgical Mask— 510(k) K223270

Substantially Equivalent

America'S Supply Chains

FDA 510(k) clearance K223270 for POSE™ Health Care Surgical Mask, Substantially Equivalent on 2022-11-01. Applicant: America'S Supply Chains.

Clearance details

Applicant
America'S Supply Chains
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Frisco, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

Source: openFDA MAUDE database, through . 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.