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FDA 510(k)

AQUA LUBE

K-Number: K110325 · 2011-12-08

Decision Date2011-12-08
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AQUA LUBE is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories, Inc.. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K110325. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUA LUBE?

AQUA LUBE is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Mayer Laboratories, Inc.. The 510(k) number is K110325.

When did AQUA LUBE receive FDA 510(k) clearance?

AQUA LUBE received FDA 510(k) clearance on 2011-12-08, under 510(k) number K110325.

Who is the listed applicant for AQUA LUBE?

The FDA 510(k) record lists Mayer Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUA LUBE?

The FDA product code for AQUA LUBE is NUC.

Other records listing Mayer Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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