DUREX PLAY MASSAGE GEL LUBRICANT— 510(k) K063385

Substantially Equivalent

Ssl Americas, Inc.

FDA 510(k) clearance K063385 for DUREX PLAY MASSAGE GEL LUBRICANT, Substantially Equivalent on 2008-03-10. Applicant: Ssl Americas, Inc..

Clearance details

Applicant: Ssl Americas, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2006-11-08
Decision date: 2008-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

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.