DeviceClearance

K091633

Substantially Equivalent

TEPHAFLEX SURGICAL FILM

Applicant
Tepha, Inc.
Product code
OOD
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lexington, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OOD

product code OOD
Death
6
Injury
1,005
Total
1,011

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.