Hyaluronic Acid Topical Wound Cream

FDA 510(k) K172747 · Virchow Biotech Pvt, Ltd.

Substantially Equivalent

510(k) numberK172747

Submission

Device name
Hyaluronic Acid Topical Wound Cream
Applicant
Virchow Biotech Pvt, Ltd.
Portland, OR, US
Received
September 12, 2017
Decision date
April 27, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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Questions and answers

When was Hyaluronic Acid Topical Wound Cream cleared by the FDA?

Hyaluronic Acid Topical Wound Cream (K172747) received a 510(k) decision of Substantially Equivalent on April 27, 2018, 227 days after the submission was received.

What is the product code of K172747?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.