GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray— 510(k) K231205

Substantially Equivalent

Gurunanda, LLC

FDA 510(k) clearance K231205 for GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray, Substantially Equivalent on 2023-08-22. Applicant: Gurunanda, LLC.

Clearance details

Applicant: Gurunanda, LLC
Product code: Code LFD
Advisory panel: Unknown
Date received: 2023-04-27
Decision date: 2023-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buena Park, CA, 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.