DeviceClearance

Natrelle 133 Plus MICROCELL Tissue Expander— 510(k) K180826

Substantially Equivalent

Allergan

FDA 510(k) clearance K180826 for Natrelle 133 Plus MICROCELL Tissue Expander, Substantially Equivalent on 2018-12-21. Applicant: Allergan.

Clearance details

Applicant
Allergan
Product code
Code LCJ
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LCJ

product code LCJ
Injury
2,704
Other
2
Total
2,706

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.