STRAITH ORAL AIRWAY— 510(k) K831078

Substantially Equivalent

Surgical Technology Laboratories, Inc.

FDA 510(k) clearance K831078 for STRAITH ORAL AIRWAY, Substantially Equivalent on 1983-06-24. Applicant: Surgical Technology Laboratories, Inc..

Clearance details

Applicant
Surgical Technology Laboratories, Inc.
Product code
Code CAE
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAE

product code CAE
Death
4
Total
4

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.