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FDA 510(k)

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

K-Number: K153678 · 2016-08-08

ApplicantPermeaderm, Inc.
Decision Date2016-08-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is the device name listed in this FDA 510(k) record. The listed applicant is Permeaderm, Inc.. It received FDA 510(k) clearance on 2016-08-08 under 510(k) number K153678. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Permeaderm, Inc.. The 510(k) number is K153678.

When did PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove receive FDA 510(k) clearance?

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove received FDA 510(k) clearance on 2016-08-08, under 510(k) number K153678.

Who is the listed applicant for PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

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

What is the FDA product code for PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

The FDA product code for PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

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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