K853917

Substantially Equivalent for Some Indications

EGNELL COMPACT SUCTION PUMP

Applicant
Egnell, Inc.
Product code
BTA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Chicago, IL, US
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Adverse events under product code BTA

product code BTA
Death
5
Total
5

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.