K052505

Substantially Equivalent

CALF IMPLANT, MODEL EC17-X

Applicant
Implantech Associates, Inc.
Product code
MIB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ventura, CA, 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, 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.