510(k) K974209— SILICONE TISSUE/INFLATABLE TISSUE EXPANDER

Substantially Equivalent

Specialty Surgical Products, Inc.

Clearance details

Applicant: Specialty Surgical Products, Inc.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1997-11-10
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, MT, 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.