510(k) K130813— MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS

Substantially Equivalent

Mentor Corp.

Clearance details

Applicant: Mentor Corp.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 2013-03-25
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Barbara, CA, US

Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

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.