AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING— 510(k) K130345

Substantially Equivalent

Mayer Laboratories, Inc.

FDA 510(k) clearance K130345 for AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING, Substantially Equivalent on 2013-08-01. Applicant: Mayer Laboratories, Inc..

Clearance details

Applicant: Mayer Laboratories, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2013-02-11
Decision date: 2013-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkely, CA, US

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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.