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FDA 510(k)

Vagisan MoistCream Cremolum

K-Number: K193444 · 2020-12-04

ApplicantDr. August Wolff GmbH & Co. KG Arzneimittel
Decision Date2020-12-04
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vagisan MoistCream Cremolum is the device name listed in this FDA 510(k) record. The listed applicant is Dr. August Wolff GmbH & Co. KG Arzneimittel. It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K193444. 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 Vagisan MoistCream Cremolum?

Vagisan MoistCream Cremolum is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Dr. August Wolff GmbH & Co. KG Arzneimittel. The 510(k) number is K193444.

When did Vagisan MoistCream Cremolum receive FDA 510(k) clearance?

Vagisan MoistCream Cremolum received FDA 510(k) clearance on 2020-12-04, under 510(k) number K193444.

Who is the listed applicant for Vagisan MoistCream Cremolum?

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

What is the FDA product code for Vagisan MoistCream Cremolum?

The FDA product code for Vagisan MoistCream Cremolum 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.

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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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