FDA 510(k)

Dermapose Access

K-Number: K200168 · 2020-04-22

Decision Date2020-04-22

Product CodeQPB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Dermapose Access is the device name listed in this FDA 510(k) record. The listed applicant is Puregraft, LLC. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K200168. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dermapose Access?

Dermapose Access is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Puregraft, LLC. The 510(k) number is K200168.

When did Dermapose Access receive FDA 510(k) clearance?

Dermapose Access received FDA 510(k) clearance on 2020-04-22, under 510(k) number K200168.

Who is the listed applicant for Dermapose Access?

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

What is the FDA product code for Dermapose Access?

The FDA product code for Dermapose Access is QPB.

Other records listing Puregraft, LLC 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.

K193363Dermapose Refresh

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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.