IMPLANTECH MEDICAL GRADE SILICONE SHEETING— 510(k) K944408

Substantially Equivalent

King & Spalding

FDA 510(k) clearance K944408 for IMPLANTECH MEDICAL GRADE SILICONE SHEETING, Substantially Equivalent on 1994-11-09. Applicant: King & Spalding.

Clearance details

Applicant: King & Spalding
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1994-09-08
Decision date: 1994-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.