ORAL NEUTRALIZER— 510(k) K071617

Substantially Equivalent

Oral Biotech

FDA 510(k) clearance K071617 for ORAL NEUTRALIZER, Substantially Equivalent on 2007-10-19. Applicant: Oral Biotech.

Clearance details

Applicant: Oral Biotech
Product code: Code LFD
Advisory panel: Unknown
Date received: 2007-06-13
Decision date: 2007-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albany, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

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.