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FDA 510(k)

SENSITIVE SKIN ANTIBACTERIAL BANDAGES

K-Number: K032983 · 2004-06-01

ApplicantScivolution, Inc.
Decision Date2004-06-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SENSITIVE SKIN ANTIBACTERIAL BANDAGES is the device name listed in this FDA 510(k) record. The listed applicant is Scivolution, Inc.. It received FDA 510(k) clearance on 2004-06-01 under 510(k) number K032983. 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 SENSITIVE SKIN ANTIBACTERIAL BANDAGES?

SENSITIVE SKIN ANTIBACTERIAL BANDAGES is a medical device that received FDA 510(k) clearance on 2004-06-01. The listed applicant is Scivolution, Inc.. The 510(k) number is K032983.

When did SENSITIVE SKIN ANTIBACTERIAL BANDAGES receive FDA 510(k) clearance?

SENSITIVE SKIN ANTIBACTERIAL BANDAGES received FDA 510(k) clearance on 2004-06-01, under 510(k) number K032983.

Who is the listed applicant for SENSITIVE SKIN ANTIBACTERIAL BANDAGES?

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

What is the FDA product code for SENSITIVE SKIN ANTIBACTERIAL BANDAGES?

The FDA product code for SENSITIVE SKIN ANTIBACTERIAL BANDAGES is FRO. This falls under the Anesthesiology category.

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Official Source

View on FDA Database →

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

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