CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)— 510(k) K240438

Substantially Equivalent

Comercializadora Brever

FDA 510(k) clearance K240438 for CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm), Substantially Equivalent on 2024-11-04. Applicant: Comercializadora Brever.

Clearance details

Applicant: Comercializadora Brever
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2024-02-14
Decision date: 2024-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leon, MX

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 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.