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FDA 510(k)

Dr. Wolff Vagisan Moisturising Cream

K-Number: K152507 · 2016-05-20

ApplicantDr. August Wolff GmbH & Co. KG Arzeimittel
Decision Date2016-05-20
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Dr. Wolff Vagisan Moisturising Cream is the device name listed in this FDA 510(k) record. The listed applicant is Dr. August Wolff GmbH & Co. KG Arzeimittel. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K152507. 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 Dr. Wolff Vagisan Moisturising Cream?

Dr. Wolff Vagisan Moisturising Cream is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Dr. August Wolff GmbH & Co. KG Arzeimittel. The 510(k) number is K152507.

When did Dr. Wolff Vagisan Moisturising Cream receive FDA 510(k) clearance?

Dr. Wolff Vagisan Moisturising Cream received FDA 510(k) clearance on 2016-05-20, under 510(k) number K152507.

Who is the listed applicant for Dr. Wolff Vagisan Moisturising Cream?

The FDA 510(k) record lists Dr. August Wolff GmbH & Co. KG Arzeimittel as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dr. Wolff Vagisan Moisturising Cream?

The FDA product code for Dr. Wolff Vagisan Moisturising Cream is NUC.

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.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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